- LOGIN
- MemberShip
- 2026-04-07 13:28:20
- Company
- Over 50,000 ppl signed 2nd petition for Trodelvy’s reimb
- by Eo, Yun-Ho May 30, 2024 05:50am
- The second petition calling for the insurance reimbursement of the breast cancer drug 'Troldelvy (sacituzumab govitecan-hziy)' has again garnered over 50,000 signatures. This is the second petition filed after the first in January that garnered 50,000 signatures. Patients are growing increasingly desperate, as 3 months have passed with little news heard on Troldelvy’s reimbursement progress. Unfortunately, with the 22nd National Assembly currently in session, it is unlikely that the agenda will be reviewed by the relevant committee. The petitioner, who described herself as a Stage IV triple-negative breast cancer (TNBC) patient on the petition board, wrote, "My tumor is growing too fast. I'm stage IV, and I beg the government to give me the chance to live," she wrote, stressing the need for Trodelvy’s reimbursement. However, no news has been heard of on its review at the DrugReimbursement Evaluation Committee stage since it passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in November last year. Gilead Sciences' triple-negative breast cancer drug Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May last year to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second or higher line of treatment for the entire TNBC patient population that has demonstrated an improvement in overall survival, but the cost-effectiveness evaluation remains a major hurdle to reimbursement. However, there is hope as another ADC, ‘Enhertu (trastuzumab deruxtecan),’ which was reimbursed in April, was recognized for innovativeness and applied a beneficial ICER from the government. Therefore, it will be interesting to see whether any progress will be made in Trodelvy's reimbursement amid the growing patients’s requests. Meanwhile, Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57% improvement in progression-free survival (PFS). These effects were observed regardless of the patient’s brain metastasis status.
- Policy
- MSD discontinues supply of Zostavax in Korea
- by Lee, Hye-Kyung May 30, 2024 05:50am
- MSD Korea has announced that it will discontinue the domestic supply of the shingles vaccine Zostavax in Korea. According to the Ministry of Food and Drug Safety, MSD reported the suspension of Zostavax to the Ministry of Food and Drug Safety on Monday. The last batch is expected to be delivered within September, but the supply period is subject to change depending on market demand. Zostavax is a shingles vaccine that was launched in 2013. It was the first live attenuated vaccine available in South Korea. According to the market research institution IQIVA, Zostavax generated KRW 22.4 billion in sales last year, which is half the KRW 55.9 billion it had posted in 2019. "The introduction of alternative shingles vaccines to Zostavax in 2017 has significantly reduced global clinical demand for Zostavax," explained MSD said in a statement. "We have decided to voluntarily discontinue the manufacture and supply of Zostavax in the global market in 2024." The company added that this decision has nothing to do with the quality or safety of the product and that the decision is based on a careful evaluation of the declining clinical demand for Zostavax due to changing market conditions and the availability of alternative vaccines. Alternatives to Zostavax include SK Bioscience's ‘SKYZoster’ and GSK's ‘Shingrix.’ "In the case of Zostavax, there are alternative shingles vaccines already available on the market," said MSD, adding, "We believe the market impact of this discontinuation will be minimal, so we are not taking any measures to facilitate supply." The last batch is planned for September 2024. "The supply period may vary depending on market demand," MSD said. "We will continue to ensure smooth supply and management of the last batch of Zostavax in Korea and any remaining product in the market, while diligently informing health authorities, relevant organizations, and healthcare providers about this decision and the processes that will follow to minimize disruption in the healthcare setting."
- Company
- 11 years since global entry…K-biosimilars
- by Chon, Seung-Hyun May 29, 2024 05:45am
- The biosimilar products developed by Korean companies are actively tapping into the global market. Celltrion received approval for Remsima in Europe in 2013. Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years. Celltrion secured 11 approvals in Europe and the United States, and Samsung Bioepis accomplished 14 approvals. According to industry sources on May 27th, Celltrion and Samsung Bioepis’ biosimilars received three approvals from Europe and the United States. On May 24th, Celltrion received the European Commission (EC) approval for its Omlyclo, a biosimilar to Xolair. The official approval was granted in two months, after the company received an approval recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in March. Omlyclo is the first Xolair biosimilar to receive European approval. Xolair is a biosimilar antibody used for persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It recorded KRW 5 trillion in global sales last year. In Omlyclo’s global Phase 3 trials, which enrolled 619 patients with chronic spontaneous urticaria across six European countries, Celltrion demonstrated Omlyclo’s equivalent efficacy to the original medicine and confirmed a similar safety profile. In two years since receiving approval for Vegzelma, a biosimilar to Avastin, in 2022, Celltrion established an additional biosimilar pipeline. This year, Samsung Bioepis received approval for its biosimilar both in Europe and the United States. Samsung Bioepis received EC approval for Pyzchiva, Stelara’s biosimilar. The company received the final approval for Pyzchiva two months after receiving a positive review for approval from the EMA’s CHMP in February. Stelara, developed by Janssen, is prescribed for treating autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It inhibits the activities of the immune response-associated inflammatory cytokine called interleukin (IL)-12 and 23. The annual global sales amount to approximately KRW 1.4 trillion. Samsung Bioepis added the product to its portfolio after receiving approval for Soliris biosimilar, Epysqli, in Europe in May last year. Samsung Bioepis received approval from the U.S. FDA for its Opuviz, a biosimilar to the macular degeneration drug Eylea. Eylea, developed by Regeneron Pharmaceuticals in the United States, is indicated for the treatment of wet (neovascular) age-related macular degeneration (AMD). Eylea’s global sales last year amounted to approximately KRW 1.3 trillion. This marks the approval of Samsung Bioepis’ biosimilar in three years, following the approval of Byooviz, a biosimilar to Lucentis, in 2021. Korean biosimilar products granted approvals in Europe and the United States. Celltrion’s Remsima, a biosimilar to Remicade, and others. Samsung Bioepis’ Benepali, a biosimilar to the autoimmune disease treatment Enbrel, and others. The current list of global entries by companies show that Celltrion has received six approvals in Europe and five approvals in the United States. Celltrion received the marketing authorization in Europe for its Remsima, titled ‘world’s first biosimilar antibody,‘ in August 2013. Subsequently, Celltrion received European approval for Truxima, a biosimilar to Mabthera, in 2017 and Herzuma, a biosimilar to Herceptin, in 2018. These drugs are immunotherapy for cancer. In November 2019, Celltrion received European approval for Remsima SC, a subcutaneous injection formulation of Remicade, and entered the market. Remsima SC is a biosimilar developed by Celltrion by changing the formulation of Remicade from intravenous (IV) to subcutaneous (SC) injection. In February 2021, Celltrion obtained European approval for its Yuflyma, a biosimilar to Humira. In August 2022, Celltrion obtained European marketing authorization for its Vegzelma, a biosimilar to Vystin. In 2016, Celltrion's Inflectra, a biosimilar to Remicade, became the first to pass the FDA approval gateway in the United States. In 2018, Truxima and Herzuma received FDA approval. In September 2022, Celltrion obtained marketing authorization for Vegzelma, a biosimilar to Avastin, from the FDA, and last year, Yuflyma, a biosimilar to Humira, also received FDA approval. In August last year, Celltrion received marketing authorization for Zymfentra, a subcutaneous (SC) formulation of the biosimilar antibody Remsima, as a novel drug. Samsung Bioepis accomplished eight approvals in Europe and six approvals in the United States. In January 2016, Samsung Bioepis began its global market expansion by obtaining approval for its Benepali, a biosimilar to the autoimmune disease treatment Enbrel, in Europe. In May of the same year, Samsung Bioepis also obtained marketing authorization in Europe for its biosimilar Flixabi, a biosimilar to the autoimmune disease treatment Remicade. In 2017, Samsung Bioepis received European approvals for its biosimilars to Herceptin, an immunotherapy for cancer, and Humira, an autoimmune disease medication. In 2020, the company successfully acquired European approval for its biosimilar to Avastin, and in 2021, it also received a marketing authorization for a biosimilar to Lucentis, an eye disease medication, in Europe. In May last year, Samsung Bioepis obtained marketing authorization from the EC for ’Episcli,’ a biosimilar to the orphan drug ’Soliris.’ Episcli is the first biosimilar developed by Samsung Bioepis in hematology. Soliris, developed by Alexion Pharmaceuticals, is a high-cost medication for refractory rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In April 2017, Samsung Bioepis received the first FDA approval in the United States for its Renflexis, a biosimilar to Remicade. In 2019, Samsung Bioepis received FDA approval for three biosimilars to Herceptin, Enbrel, and Humira. In January 2019, Ontruzant, a biosimilar to Herceptin, received marketing authorization in the United States, followed by Eticovo and Hadlima, biosimilars to Enbrel and Humira, in April and July of the same year, respectively. Samsung Bioepis obtained FDA approval for its Byooviz, a biosimilar to Lucentis, in the United States in September 2021. Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years, following Celltrion’s European approval for Remsima in 2013. The companies strengthened global targeting, entering over two products annually into the United States and Europe.
- Company
- Six pharmaceutical companies challenge the 'Esgliteo' patent
- by Kim, Jin-Gu May 29, 2024 05:45am
- Generic companies have claimed patent challenges against Boehringer Ingelheim’s combination therapy for diabetes, 'Esgliteo (empagliflozin+linagliptin).' It is the strategy of six companies, including Boryung, to launch their generics early by avoiding or nullifying the patent of this combination therapy, which contains SGLT-2 inhibitor and DPP-4 inhibitor ingredients. According to pharmaceutical industry on May 28th, the six companies, including Boryung, Dongkook Pharm, Aprogen, Korea Prime Pharm, and Daehwa, filed claims for passive trials to confirm the scope of a right involving the Esgliteo patent. These companies also filed a claim for a nullification trial for the same patent. In the case of a nullification trial, Genuonesciences has already filed a claim for a trial last month. Consequently, generic companies are challenging both avoidance and nullification of a single patent. Esgliteo is protected by the patent titled 'A pharmaceutical composition including glucopyranosyl-substituted benzene derivatives' until August 2028. However, this patent is not listed on the Ministry of Food and Drug Safety (MFDS) list. This strategy is similar to that of Boehringer Ingelheim, where Jardiance (empagliflozin) and Trajenta (linagliptin) were not patented. The companies challenging patents aim to launch their generics after either avoiding or nullifying the Esgliteo patent. Since they are challenging a single patent with two approaches simultaneously, the analysis indicates that they are eager to overcome the patent. The generic version of linagliptin is expected to launch after the Trajenta substance patent expires next month. If the companies successfully challenge Esgliteo patent, they can expand their portfolio of linagliptin-based combination therapy. The remaining hurdle is the possibility of an unregistered patent. Similar to the cases of Jardiance and Trajenta, there may be unregistered patents. The analysis suggests that the product approval is not affected by the remaining unregistered patent challenge, but there may be a patent infringement possibility when products are launched. Meanwhile, Esgliteo has the highest prescription sales among combination therapies, consisting of SGLT-2 inhibitor and DPP-4 inhibitor, for diabetes. According to market research firm UBIST, Esgliteo a generated prescription amount of KRW 2.7 billion. This is higher than KRW 2.2 billion of LG Chem’s 'Zemidapa (dapagliflozin+gemigliptin),' KRW 2.1 billion of AstraZeneca’s 'Qtern (dapagliflozin+saxagliptin),' KRW 600 million of CKD Pharm’s 'Exiglu S (dapagliflozin+sitagliptin),' and KRW 500 million of Dong-A ST’s 'Sugadapa (dapagliflozin+evogliptin).' Esgliteo generated KRW 2.5 billion this year in the first quarter, similar to last year’s annual prescription performance. The pharmaceutical industry anticipates that other generic companies may challenge the patent additionally because Esgliteo sales are rapidly increasing.
- Company
- High-dose Eylea is approved in KOR
- by Son, Hyung-Min May 29, 2024 05:45am
- Dr. Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital) The higher-dose version of Eylea, which more than doubles the dosing interval, has been approved in Korea. With the approval, Eylea now owns the longest duration of effect among its competitors. Bayer held a press conference in Yeouido, Seoul, on the 28th to celebrate the approval of Eylea High Dose (8mg) in Korea. Eylea is a treatment for age-related macular degeneration and diabetic macular edema developed by Bayer and Regeneron. The higher dose was approved in April of this year, nearly a decade after the lower dose (2 mg) was approved in 2013 Eylea binds to the vascular endothelial growth factor (VEGF)-A and B and growth factors in the retina, inhibiting VEGF from binding to its native receptor and activating it. Bayer sought to receive approval for the higher dose of Eylea due to its extended dosing interval. While the current lower dose Eylea requires dosing every two months, the higher dose Eylea will extend the dosing interval to up to 5 months. The approval of the high-dose Eylea was based on the PULSAR study in patients with macular degeneration and the PHOTON study in patients with diabetic macular edema. The PULSAR trial, which was conducted on 1,009 patients with nAMD, compared the efficacy of high dose and low dose Eylea. Trial results showed that Eylea 8mg administered every 12 and 16 weeks were non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval. The high dose Eylea also demonstrated noninferiority to low dose Eylea in the PHOTON study that was conducted on 658 patients with DME. Results showed that Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48. The high dose Eylea is expected to compete with Roche's Vabysmo in the market. Vabysmo had demonstrated non-inferiority to the lower dose of Eylea at a dosing interval of once every 4 months. "The high dose will be highly useful for patients whose symptoms are not controlled with the low dose Eylea," said Dr. Jae Hui Kim, Director of Future Planning of the Korean Retina Society (Kim’s Eye Hospital). "As Eylea is a well-verified drug, we expect the higher dose to bring similar results as well.” "Among the many available treatment options, I would first prescribe high dose Eylea to patients who have not responded to lower doses. Also, if given the choice between the low and high doses of Aylia, I think most patients will want to start with the high dose because of the dosing interval benefit."
- Company
- 'Camzyos' anticipated for the DREC review consideration
- by Eo, Yun-Ho May 29, 2024 05:45am
- The industry is awaiting the progress on whether 'Camzyos,' the first novel drug for obstructive hypertrophic cardiomyopathy (oHCM), will receive an insurance reimbursement listing. According to industry sources, BMS Korea’s novel drug Camzyos (mavacamten) has cleared the review by the Economic Evaluation Committee of Health Insurance Review and Assessment Service (HIRA). It is now being scheduled for the Drug Reimbursement Evaluation Committee (DREC) review. It is expected that Camzyos will be considered for the DREC review in June. Because Camzyos is the first treatment option for the particular disease to receive a review, it is to be watched what outcome will be yielded from the first attempt. Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Its underlying mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Because no treatments have been available to treat oHCM for a long time, Off-label medications were used to manage symptoms. Because of Camzyos, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Considering these factors, Camzyos appears to have met the criteria of an innovative new drug, announced by the government last year: ▲There are no alternative products, therapeutically equivalent products, or therapies available ▲Extending the survival period significantly and showing clinically meaningful improvements ▲Has been approved for MFDS’ GIFT (priority review designation), U.S. FDA’s BTD, or Europe’s EMA expedited review (PRIME). Meanwhile, Camzyos demonstrated efficacy through Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), by more than twofold compared to the placebo. 20% of the Caymzyos treatment group met NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by fourfold after exercise. 10 out of 7 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effect for 30 weeks. Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital, said, "On the surface, the reimbursement listing of Camzyos may seem like a burden to the National Health Insurance finance, but if we expand our view, it’s the opposite. If we neglect oHCM patients without offering the treatment, there will be an increased risk of cardiovascular episodes, which will, in turn increase medical spending directly and indirectly."
- Policy
- Antengene starts Xpovio's reimb pricing negotiations in KOR
- by Lee, Tak-Sun May 29, 2024 05:45am
- The Chinese pharmaceutical company Antengene has started pricing negotiations with the National Health Insurance Service for its multiple myeloma drug ‘Xpovio Tab (Selinexor),’ bringing near its reimbursement listing in Korea. Xpovio was approved in July 2021 as a treatment for blood cancer. At the time of its approval, it became the first new drug developed by a Chinese pharmaceutical company to be approved by Korea’s Ministry of Food and Drug Safety. However, it has faced many challenges during the health insurance reimbursement review after its approval. According to industry sources on the 28th, Antengene recently started drug pricing negotiations with the National Health Insurance Service for its Xpovio Tab. The drug was deemed adequate for reimbursement only for the multiple myeloma indication after HIRA’s Drug Reimbursement Evaluation Committee (DREC) review on the 2nd of this month. The drug has passed DREC review at its second attempt. Xpovio received domestic approval in August 2021. It is indicated ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. Of these, only the multiple myeloma indication was approved as adequate for reimbursement. In June last year, the Cancer Disease Review Committee also set reimbursement standards only for the multiple myeloma indication. At the time, the drug's reimbursement application was rejected by DREC in November of the same year. Antengene Korea, which imports and sells the drug, started preparations again with grit and submitted an application again in February, and succeeded in being recognized as adequate for reimbursement in May, but just for the multiple myeloma indication. Before the DREC review, the Korea Multiple Myeloma Patient Group had issued a statement urging the Korean government to reimburse Xpovio Tab, due to lack of other alternative treatments. In its request, KMPG stressed how the drug is covered in all A8 countries that are used as a reference for new drug registration in Korea. At the time Xpovio was approved in Korea, the drug was not listed in any of the A8 countries. However, starting with Canada in 2022, it is now reportedly listed in all A8 countries, including the United States, United Kingdom, Germany, France, Italy, Switzerland, and Japan. If the company and HIRA reach an agreement during the drug pricing negotiations, it will be reimbursable in Korea. If so, it will become the second reimbursed drug developed by a Chinese pharmaceutical company after Brukinsa. Therefore, it will be interesting to see if it will successfully pass the final stage of negotiations with the MFDS and be reimbursed as requested by patients.
- Policy
- Only 15 of the 61 Trajenta generics will be released in KOR
- by Lee, Tak-Sun May 29, 2024 05:45am
- Despite the expiry of the substance patent of the DPP-4 inhibitor diabetes drug Trajenta (linagliptin) set for the 8th of next month, most of its generic versions will not be launched at that time. Only products with the first generic exclusivity will be released, and the rest will only be allowed sale in March next year after the sales ban period is lifted. According to industry sources on June 28, a total of 15 generic versions of Trajenta will be listed with reimbursement on June 9. On the day, the following pharmaceutical companies will be launching generic versions of Tragenta: Korea Arlico Pharm, Hutecs Korea Pharmaceutical, Alvogen Korea, Aju Pharmaceutical, Boryung Pharmaceutical, Hanlim Pharma, Dongwha Pharmaceutical, Ildong Pharmaceutical, Hana Pharm, Kukje Pharm, KyungDong Pharm, Shinil Pharm, Huons, Daewon Pharm, and DonKoo Bio&Pharma will release generic versions of Trajenta monotherapy. The absence of large generic companies in the monotherapy market is notable. This is in contrast to the 29 companies releasing the linagliptin 5mg + metformin hydrochloride 1g combination drug. The reason why only 15 companies, mainly small and medium-sized pharmaceutical companies, are launching Trajenta generic monotherapy is due to the first generic exclusivity. The 15 companies received the right to first generic exclusivity in February 2019. They were able to avoid Trajenta’s crystalline patent and secure the right to market the drug first upon their approval. The companies will have exclusive rights to market the drug until March 8, 2025. This means that before March 8, 2025, the sale of drugs that are identical to the products that have obtained first generic exclusivity is prohibited. 42 generic drugs have been approved, excluding 19 that have obtained first generic exclusivity. These can only be launched after March 8th of next year. Their launch date has been delayed by 9 months due to the failure to obtain the first generic exclusivity rights. As it is important for generic products to preoccupy the market, the products that failed to obtain first generic exclusivity are now put in a much more disadvantageous position as they would have to enter the market 9 months later than the competitors. In response, 4 companies, including Mother's Pharmaceutical, received approval for salt-modified versions to bypass the first generic exclusivity. Since salt-modified products are not identical to the original drug, they can be released regardless of the first generic exclusivity rights. They will also receive a drug pricing premium, and be priced at KRW 675 per unit, making them the highest-priced among follow-on Trajenta monotherapies.
- Company
- Multinational pharmaceutical companies post mixed results
- by Son, Hyung-Min May 28, 2024 01:31pm
- The Korean subsidiaries of multinational pharmaceutical companies posted mixed performances last year. Sales of Pfizer Korea, MSD Korea, and Gilead Sciences Korea, which developed COVID-19 vaccines and treatments, plummeted due to the base effect of the pandemic. On the other hand, GlaxoSmithKline (GSK) and Amgen Korea saw sales increase thanks to the growth in sales of their innovative new drugs. According to the Financial Supervisory Service on Saturday, the sales of 36 major multinational pharmaceutical companies in Korea fell 12.5% to KRW 10.37 trillion last year from KRW 11.84 trillion in 2022. Of the 36 MNCs, 12 companies, including Pfizer, MSD, Janssen, Gilead, Bayer, Alcon, Lilly, MundiPharma, Ipsen, Teva-Handok, and Biogen, saw a sales decline. The company that saw the largest decline was Pfizer. Last year, the company's revenue fell 50.3% YoY to KRW 1.60 trillion. The company's sales surged from 2021 supplying the COVID-19 vaccine Comirnaty and the treatment Paxlovid. The company's sales soared to KRW 391.9 billion in 2020, KRW 1.70 trillion in 2021, then to KRW 3.23 trillion in 2022, but as the number of COVID-19 patients started to decrease with the endemic, the company's sales fell by half last year. As the government took charge of the distribution and marketing of COVID-19 vaccines at the time, the company was able to generate high profits due to low SG&A costs. MSD Korea's revenue fell 7.3% from KRW 820.4 billion in 2022 to KRW 760.9 billion last year. After posting sales of KRW 471.6 billion in 2019 and KRW 541.9 billion in 2021, MSD Korea’s sales surged to exceed KRW 800 billion in 2022 but then saw a slight decline last year. According to the market research firm IQVIA, sales of its flagship product Keytruda increased 66.4% from KRW 239.6 billion in 2022 to KRW 398.7 billion last year. However, the company attributed the decline to a drop in sales of its diabetes drug Januvia and COVID-19 drug Lagevrio. Gilead posted sales of KRW 384 billion last year, down 32.1% YoY. Gilead also saw a decline in prescriptions for its COVID-19 drug Veklury, which led to a sales decline. This is due to a sharp decline in the number of patients with COVID-19 and a significant drop in the number of critically ill patients. Veklury is used for patients hospitalized with severe COVID-19 who are below 94% oxygen saturation or require supplemental oxygen therapy. Meanwhile, AstraZeneca, which was the first to develop a COVID-19 vaccine, saw a slight increase in sales. AstraZeneca Korea's sales rose 3.9% from KRW 616.1 billion in 2022 to KRW 639.3 billion last year. AstraZeneca Korea posted sales of KRW 655.3 billion in 2021, up 31.6% YoY, driven by the launch of its COVID-19 vaccine. However, the company's sales fell slightly to KRW 615.1 billion in 2022 with the introduction of vaccines by Pfizer, Moderna, and Janssen. AstraZeneca Korea’s sales rebounded last year thanks to the strong performance of its anticancer drugs. Sales of the company’s lung cancer drug Tagrisso rose 4.2% YoY to KRW 110.9 billion based on IQVIA, while the immuno-oncology drug Imfinzi generated KRW 82.7 billion in sales last year, up 57.9% from the KRW 52.4 billion in 2022. Sales of the breast cancer drug Lynparza increased 22.2% year-on-year. In addition, Alcon Korea (-21.4%), Lilly Korea (-15.8%), Sanofi Pasteur (-6.2%), Bayer Korea (-3.0%), and Janssen Korea (-2.7%) also saw a sales decline. GSK-Amgen-Sanofi post sales gains...driven by innovative new drugs GSK, Amgen, and Sanofi-Aventis posted sales increases last year, driven by sales of innovative new drugs. GSK posted sales of KRW 385.1 billion last year, up 39.6% from KRW 275.8 billion in 2022. GSK's growth was driven by its shingles vaccine, Shingrix. Last year, Shingrix was the top seller in the shingles vaccine market, with sales of KRW 38.5 billion, according to IQVIA. The fact that two domestic pharmaceutical companies joined to sell and promote Shingrix also contributed to its rapid market penetration. GSK partnered with GC Biopharma and Kwangdong Pharmaceutical to promote sales of Shingrix in Korea. Also, sales of GSK's benign prostatic hyperplasia combination drug Duodart increased 186.5% YoY. Amgen Korea posted sales of KRW 228.8 billion last year, up 33.3% YoY. Its innovative new drugs, including Prolia, Xgeva, and Repatha contributed to the sales growth. According to the market research institution IQVIA, Amgen's Prolia generated KRW 151.1 billion in sales last year, up 30.6% YoY. This is a 64.0% increase in two years from KRW 92.1 billion in 2021. Launched in Korea in November 2016, Prolia is a biologic osteoporosis treatment that targets the RANKL protein, which is essential for the formation, activation, and survival of bone-destroying osteoclasts. Sales of Repatha, a PCSK9 class dyslipidemia treatment, exceeded KRW 10 billion for the first time last year with 10.5 billion won. Sales of Xgeva, which was released as a double-dose strength of Prolia, also exceeded KRW 10 billion for the first time last year. Sanofi-Aventis Korea's sales totaled KRW 501.8 billion last year, up 3.7% YoY. The company saw steady sales growth, adding an indication for its biological agents Dupixent and Eloxatin. According to market research firm IQVIA, Dupixent generated sales of KRW 143.2 billion last year, up 36.1% YoY. Dupixent is a first-in-class drug that targets the signaling of interleukin (IL)-4 and IL-13, which are major contributors to type 2 inflammation. It has been shown to be effective in inflammatory diseases such as asthma and atopic dermatitis. Last year, Eloxatin's sales reached KRW 43.6 billion, up 2.8% YoY. Sales of Eloxatin, which was approved in Korea in 2005, have been on a slight decline since 2019, but have exceeded KRW 40 billion on average from 2020 to last year.
- Company
- Handok strengthens global pharma partnerships
- by Kim, Jin-Gu May 28, 2024 05:52am
- Handok is strengthening its partnerships with global pharmaceutical companies. At the end of last year, Handok signed deals with the Dutch company Argenx and Swedish biopharmaceutical company Sobi for three rare disease treatments. This year, the company also launched a combination therapy for high blood pressure co-developed with Sanofi. On May 24, Handok signed a deal with India’s global pharmaceutical company Biocon for liraglutide, a GLP-1 agonist used to treat diabetes and obesity. Handok plans to fill the pipeline gap caused by patent expiration and license endings through these partnerships. Handok signs a licensing deal with India’s pharmaceutical company Biocon for a product containing the same active ingredient as Saxenda According to industry sources on May 25th, Handok signed a licensing deal with India’s global pharmaceutical company Biocon for liraglutide. Liraglutide is the same active ingredient as Novo Nordisk’s diabetes and obesity treatments, Victoza and Saxenda. Handok stated that this product has not yet been launched in the global market, but it recently received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Its global product name has not been determined. Handok signed a licensing deal with India’s pharmaceutical company Biocon for a product containing the same active ingredient as Saxenda. It is expected to be commercialized in South Korea after 2025. Saxenda and Victoza’s patents are set to expire by 2025. Saxenda is protected by two accounts of patents, each expiring in November this year and November next year. Victoza has four patents registered, and one has already expired. The expiration dates for the rest are June 2024, November 2025, and March 2037. However, the patent set to expire in 2037 is based on Liraglutide’s effect on cardiovascular diseases. Handok will not infringe on patents by launching Liraglutide after 2025 and by not commercializing it for the purpose of treating cardiovascular disease. Although new obesity drugs of the GLP-1 class, like Wegovy and Mounjaro, have not been officially launched in South Korea, the industry has a high expectation for follow-up drugs with the same active ingredient since Saxenda is practically dominating the obesity treatment market. According to a pharmaceutical market research company IQVIA, Saxenda topped KRW 66.8 billion in sales last year, up 13% YoY. The stock market response is also positive. On May 24th, Handok’s stock hit KRW 17,010, up 23.3% from the previous day. It was the highest amount in recent years, and the analysis suggests that Hadok’s announcement to introduce GLP-1 obesity and diabetes treatments has been viewed as good news. Introduced three orphan drugs consecutively…co-developed a hypertension drug with Sanofi In the second half of last year, Handok initiated partnerships with global pharmaceutical companies In September last year, Handok signed an exclusive marketing deal with Dutch Argenx for VYVGART, a treatment for myasthenia gravis. VYVGART is the first-in-class subcutaneous formulation for myasthenia gravis to be approved by the U.S. FDA. In October, Handok signed a strategic partnership deal with Sweden’s global pharmaceutical company Sobi, introducing two rare disease drugs, Empaveli and Doptelet. Empaveli targets an adult patients with paroxysmal nocturnal haemoglobinuria (PNH). It has received approvals in the United States, Europe, Australia, and Japan. Doptelet is indicated to treat adult patients with primary chronic immune thrombocytopenia (ITP). Last year, Handok introduced three rare diseas drugs, VYVGART, Empaveli, and Doptelet, to South Korea. In February, Handok launched ‘Aprovasc,‘ a combination therapy for hypertension that was co-developed with Sanofi, in South Korea. It is the first combination therapy of amlodipine and irbesartan, to receive approval in South Korea. In October 2019, Handok signed a licensing deal with Sanofi for the domestic development, manufacturing, and approval for a combination therapy to treat high blood pressure. In November, Aprovasc received the approval of the Ministry of Food and Drug Safety (MFDS). Sanofi has development and marketing rights as an original developer, and Handok will be responsible for domestic manufacturing and co-promoting Aprovasc with Sanofi. Will it fill the gap left by the patent expired 'Tenelia' and licensing retrieved 'Soliris'? Handok plans to expand cooperation with global pharmaceutical companies to fill the gap left by previous core products. Previously, Handok had Tenelia·Tenelia M, diabetes treatments of the DPP-4 inhibitor class, and Soliris and Ultomiris, rare disease treatments, as its key pipeline. However, in October 2022, Tenelia’s substance patent expired. Consequently, a many Tenelia generics were launched. In February last year, AstraZeneca Korea retrieved sales rights of Soliris and Ultomiris. Initially, Handok introduced these two drugs to South Korea from Alexion Pharmaceuticals. When AstraZeneca acquired the original developer Alexion Pharmaceuticals, the domestic sales rights transferred to AstraZeneca Korea. Handok had a sales gap from its previous core products for chronic diseases, Tenelia (left), due to patent expiration, and for rare disease area core products, Soliris (middle) and Ultomiris (right), due to sale rights retrieval. Consequently, Handok was left with no drugs related to diabetes treatment and rare disease treatment, which used to be its key pipeline. Handok plans to fill the gap in rare disease treatment area with VYVGART, Empaveli, and Doptelet. Empaveli and Doptelet are considered to be the suitable substitutes as they have indications for PNH and myasthenia gravis, as in Soliris and Ultomiris. Furthermore, Handok is expected to succeed in the novel drug market since it has already established a business network by overseeing domestic sales of Soliris and Ultomiris after these drugs received reimbursement coverage in 2018. Additionally, Handok plans to fill the gap in chronic disease treatment area with Aprovasc, a combination therapy for treating high blood pressure, and liraglutide, a treatment for diabetes and obesity. Handok aims to expand to the high blood pressure market, which was previously its weakness, with Aprovasc. And, its diabetes treatment portfolio is expected to grow with liraglutide. Handok’s diabetes portfolio includes various diabetes drugs, including the sulfonylurea (SU) class ‘Amaryl,‘ the SGLT-2 inhibitor class ‘Suglat,‘ the DPP-4 inhibitor class ‘Tenelia,‘ and medical devices, such as blood glucose monitoring device. Adding liraglutide to this list will strenghthen Handok’s completion of the diabetes portfolio.
