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- 2026-05-08 02:20:18
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- GC Pharma reinforces sales partnerships
- by Kim, Jin-Gu Feb 13, 2023 05:58am
- GC Pharma has been strengthening partnerships with pharmaceutical and biohealth companies in Korea and abroad by signing a series of copromotion agreements. After the company signed a copromotion agreement for GSK’s shingles vaccine ‘Shingrix’ at the end of last year, the company recently also signed an agreement to copromote Sanofi's anti-platelet agent ‘Plavix.' Also, earlier this year, the company expanded its sales agreement with BMS on selling the company’s hepatitis B treatment, ‘Baraclude.’ The industry interpreted this as the company’s move to diversify its business structure, focusing on blood derivative products and vaccines and securing a cash cow through external expansion. ◆Will copromote Shingrix and Plavis...expanded sales agreement for Baraclude According to industry sources on the 11th, GC Pharma has been jointly selling Sanofi’s anti-platelet agent Plavix (clopidogrel) from the first of this month. Under the copromotion agreement, GC Pharma is responsible for local sales, and Sanofi for sales at large hospitals. Plavix has been generating KRW 120 billion in the outpatient prescription market in Korea. According to the pharmaceutical market research institution UBIST, Plavix sold KW 117.6 billion last year, ranking fourth among all prescription drugs sold in Korea last year. (From the left) Shingrix, Plavix, Baraclude Also, the company had signed a copromotion agreement for GSK’s shingles vaccine Shingrix with GSK and Kwangdong Pharmaceutical and started joint sales of the drug in earnest in December last year. Shingrix has been gaining attention as a new premium vaccine in its area. It has shown a near 97% efficacy, twice higher than that of other existing shingles vaccines, and has demonstrated its long-term effect and safety. It had already raised KRW 2.26 trillion in sales in the global market in the first half of last year, which is near the KRW 2.70 billion that the vaccine had made in the previous year. Earlier this year, the company expanded its sales agreement for the hepatitis B treatment Baraclude with BMS. The company, which had previously jointly sold the product with BMS in the past, will exclusively distribute and sell the drug from this year. Therefore, the company will be selling the drug to all medical institutions including general hospitals in addition to local hospitals and clinics in Korea. Baraclude is a hepatitis B treatment that contains entecavir. The drug sold KRW 71 billion in prescriptions last year. Although its generic version has been released in the market after patent expiry, the original drug continues to exert an overwhelming influence in the market. Last year, it ranked second in sales in the market after Gilead Sciences Viread (KRW 89.5 billion). ◆Suceeds in joint sales of its self-developed Neulapeg·Shinbaro with domestic companies The company has also been strengthening partnerships with domestic pharmaceutical companies. GC Pharma has been adopting the strategy of jointly selling its self-developed drugs with domestic pharmaceutical companies. Neulapeg and Shinbaro are representative examples of such activity. Neulapeg is a treatment for Neutropenia that had been self-developed by GC Pharma. It is a biobetter product that is an upgraded version of the original drug, Kyowa Kirin’s Neulasta. It has improved purity and stability compared to existing treatments and reduced the drug’s half-life over existing drugs. GC Pharma has been jointly selling Neulapeg with Boryung Pharmacuetical until 2021, then with Jeil Pharmaceutical from last year. Its sales had surged during its partnership with Boryung Pharmacuetical. Its sales, which had been less than KRW 1 billion every quarter until 2018, surged to nearly KRW 6 billion in 2021 and exceeded that of the original version by Q4 2021. ◆ Strategies to fill the gap derived from non-sale of MSD vaccines + expanding business portfolio The domestic sales license transfer of the 3 MSD vaccines is pointed out as the background for GC Pharma’s recent moves. Until 2020, GC Pharma had been copromoting 3 of MSD’s vaccines: the shingles vaccine Zostavax, and cervical cancer (HPV) vaccines Gardasil 4 and Gardasil 9. Sales of the 3 vaccines reached KRW 106.1 billion in 2020. However, MSD changed its domestic copromotion partner for the three vaccines to HK inno.N in 2020. Since then, the company has been actively filling the gap that occured in its revenue by making new copromotion agreements. In the mid-to-long term, this is also in line with GC Pharma’s recent business structure diversification strategy. GC Pharma has recently been aggressively strengthening its prescription drug business. It plans to expand its business portfolio, focusing on existing blood derivative products and vaccines. Due to the heavily export-dependent nature of blood derivative products and vaccines, the disadvantage is that its sales are volatile depending on the overseas performance and period. This is why the company has established a mid-to-long strategy to expand its field to prescription drugs and secure a new cash cow.
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- Can Jakavi be reimbursed for GvHD within the year?
- by Eo, Yun-Ho Feb 13, 2023 05:58am
- Whether reimbursement of ‘Jakavi’ be extended to cover Graft versus Host Disease (GvHD) is gaining attention. Novartis Korea submitted an application to extend reimbursement of its Jakavi (ruxolitinib) to GvHD immediately after receiving approval for the indication in May 2022. However, 8 months have passed and no progress has been made at the Health Insurance Reimbursement and Assessment Service’s level. Therefore, whether the agenda will be deliberated during HIRA’s Drug Reimbursement Evaluation Standard Subcommittee meeting that is expected to be held within the week is gaining attention. When considering the remaining review process, it may be difficult to extend the drug’s reimbursement within the year if HIRA does not complete evaluations by the first half of this year. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation (allo-SCT). The donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damage them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar outcomes in the field, opening up new possibilities for patients suffering from lack of an appropriate treatment option” He added, “Treatment access to Jakavi has been restricted in Korea due to its non-reimbursement. A considerable amount of time has passed since its approval, and Jakavi’s reimbursement should be applied as soon as possible so as not to further increase the burden of the patients that have already suffered enough, from hematopoietic stem cell transplantation to GvHD.” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62%, which was higher than the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be nearly twice higher in the Jakavi group at Day 56 at 40% (34/155), compared with the 22% (61/154) in the control group.
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- One step left to Dupixent’s reimb in pediatric patients
- by Eo, Yun-Ho Feb 10, 2023 05:53am
- The atopic dermatitis treatment ‘Dupixent’ has entered the last phase of extending its reimbursement coverage to children and adolescents. According to industry sources, Sanofi-Aventis Korea is conducting drug pricing negotiations for the low-dose formulation (200mg) of Dupixent (dupilumbab) with the National Health Insurance Service. The reimbursement agenda has made smooth progress after passing deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service on the 12th of last month. When considering the set negotiation period, the results are expected to come out by March. Being an RSA (Risk Sharing Agreement) drug and the addition of the separate 200mg dose, the drug had to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service to receive reimbursement. If the drug successfully completes drug pricing negotiations, Dupixent will finally be able to see results two years after applying for the reimbursement extension in April 2021. The journey had not been so easy for the drug. IT first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were only set in May last year. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent. The two drugs were both listed for reimbursement in May last year and Rinvoq is also attempting to extend its reimbursement to pediatric adolescent patients. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
- Company
- Botulinum Xeomin can be stored at room temperature
- by Jung, Sae-Im Feb 10, 2023 05:52am
- Professor Heo Chang-hoon presenting at the Merz Xeomin press conference"Improving toxin quality and strengthening management change perceptions Merz's botulinum toxin Xeomin has been upgraded to room-temperature storage. It emphasized quality as the only room-temperature storage product with the highest purity among botulinum toxin drugs on the market in Korea. Merz held a press conference at the Grand InterContinental Seoul Parnas Hotel in Gangnam-gu, Seoul on the 9th to commemorate the Xeomin room temperature storage (1 to 25 degrees Celsius). Launched in 2011, Xeomin has recently changed its license for storage temperatures. Unlike other botulinum toxin preparations that require refrigeration at 2 to 8 degrees, Xeomin can be stored at 9 to 25 degrees Celsius. It is the only toxin product on the domestic market that is stored at room temperature. In order for biological agents such as botulinum toxin to be licensed for upper marriage storage, consistent effectiveness, and stability must be demonstrated at 1 to 25 degrees. As a result of the experiment, Xeomin confirmed that biological activity and human serum albumin content remained constant for 36 months under conditions of 25 degrees Celsius and 60% humidity. Director Park Je-young (Oracle Dermatology in Apgujeong), who served as the speaker of the meeting, said, "Xeomin has already been allowed to be stored at room temperature in the U.S. and Europe. This means that there is a low risk of decomposition and deterioration of products that may occur due to temperature changes during transportation or distribution," he explained. As a result, Xeomin is the only botulinum toxin preparation that removes complex proteins and can be stored at room temperature at the same time. It minimized the risk of developing resistance by leaving only neurotoxin, an active substance, and proved high stability by storing it at room temperature. Heo Chang-hoon, a dermatologist at Seoul National University Bundang Hospital, said, "Botulinum toxin is determined based on ▲ the purity of neurotoxin ▲ consistency of effect expression ▲ stability during distribution and storage." In particular, toxin preparations are often not consistently refrigerated in storage and movement, and Xeomin has achieved the desire of all medical staff and pharmaceutical companies to store them at room temperature, he added. Yoo Soo-yeon, CEO of Merz, said, "This permit can save the use of energy essential for refrigeration, which is in line with the ESG management pursued by Merz."
- Company
- 80 billion won worth of Anticonvulsant Market
- by Nho, Byung Chul Feb 09, 2023 05:49am
- In the 80 billion Anticonvulsant market, Topiramate-based treatments form 30 billion units, leading the market. The epilepsy drug consists of about 10 components, including Topiramate, Lamotrigine, sodium Valproate, Oxcarbazepine, and Perampanel. According to the drug distribution performance data, as of last year, the performance of Lamotrigine, sodium valproate, Oxcarbazepine, and Perampanel drugs was 14.9 billion won, 10.4 billion won, 7.6 billion won, and 4.5 billion won, respectively. It is also notable that the rest of the formulations, excluding topiramate, show an annual growth rate of around 100 million won to 300 million won. About 10 products of Topiramate formulations have been released, forming the largest number of epilepsy drugs. Total sales in 2018, 2019, and 2020 were 23.2 billion won, 25.7 billion won, and 28.9 billion won, with the highest growth rate. The leading product of topiramate ingredients was the Janssen Topamax Sprinkle capsule, which generated about 10 billion won in sales last year. SK Chemicals Qudexy and Huons Ceti followed with 2.2 billion won and 2.1 billion won. GSK Lamicta, the No. 1 product of Lamotrigine ingredients, maintained its appearance of 11.9 billion won in 2021. It has the highest performance based on a single product of epilepsy drugs. Lamostal and Bukwang Lamotigine ranked second and third in the same ingredient, which recorded 800 million won 600 million won in performance. Myungin Camazepine and Novartis Tegretol Korea form an appearance of 2.9 billion won and 2.4 billion won. Perampanel-based product Eisai Korea Fycompa's 2021 performance is 4.5 billion won, while Handok Sentil is moving within 900-1 billion won for five years. According to academia, the prevalence of epilepsy is about 4 to 10 per 1,000 people, and it is known that 20 to 70 people per 100,000 people occur newly every year, especially in childhood (under 9) and old age (over 60). Genetic defects cannot be excluded as the cause of epilepsy, but it is a general classification criterion to classify it into structure, metabolism, and unknown cause. It is a case of seizures due to acquired diseases such as stroke, brain damage, and infection due to structural and metabolic causes, and can come from brain nerve cell stimulation due to hypoglycemia, uremia, withdrawal of alcohol, and sleep deprivation. Most likely causes include cerebrovascular disease, encephalitis, hippocampus sclerosis, cerebral palsy, brain tumors, vascular deformities, and degenerative diseases, but more than half of the causes are unknown. Looking at the guidelines for treatments of the Korean Epidemiology Association, epilepsy can be improved with drug treatment, and 60-70% of patients can control seizures with treatments. Since drug treatment should be maintained for a long period of at least two years, it is important to choose a drug that suits each patient's condition.
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- Olumiant may land to treat alopecia areata in KOR this year
- by Eo, Yun-Ho Feb 09, 2023 05:49am
- The JAK inhibitor ‘Olumiant’ may be prescribed to treat hair loss in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is conducting a review on expanding the indication of Lilly Korea’s JAK inhibitor Olumiant (baricitinib) to severe alopecia areata in Korea. The company may receive the final marketing authorization for the indication in the first half of the year at the earliest. Olumiant was approved for the alopecia areata indication in the US and Japan in June last year and received a recommendation for its use in the EU as well. With the approvals, the drug is quickly making its way into the global market. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in some countries including Korea. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows, and eyelashes can also fall out. The efficacy of Olumiant was demonstrated through the BRAVE-AA1 and BRAVE-AA2 trials that were conducted on patients with severe alopecia areata. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with the placebo. In the AA1 trial, 22% of the 184 patients in the Olumiant 2mg arm and 35% of the 281 patients in the Olumiant 4mg arm showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiang 4mg arm achieved a SALT score of 20 or less, which was a significantly higher proportion than the 2.6% in the placebo arm. Reimbursement for Olumiant was extended to atopic dermatitis in May last year after being first listed for rheumatoid arthritis in 2018.
- Company
- Entresto’s sales exceeded KRW 40 billion last year
- by Feb 08, 2023 05:53am
- Pic of Entresto Sales of Novartis Korea’s chronic heart failure treatment ‘Entresto’ has exceeded KRW 40 billion 6 years into its release. According to market research institution UBIST on the 7th, Entresto’s outpatient prescription sales had recorded KRW 40.6 billion last year. This is a 26% increase from the KRW 32.3 billion it had recorded the previous year. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) 'valsartan' and neprilysin inhibitor 'sacubitril.' The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction as an alternative to other heart failure treatments. Entresto received marketing authorization in April 2016 and the drug was officially launched with reimbursement in October 2017. Although the drug recorded KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then exceeded KRW 30 billion and recorded KRW 32.3 billion in 2021. Data: UBIST The drug’s quarterly sales first exceeded KRW 10 billion for the first time last year. Last year, Entresto raised sales of KRW 9.1 billion in Q1, then KRW 9.6 billion in Q2, then KRW 10.5 billion in Q3. In Q4, its sales continued to rise to record KRW 11.4 billion in Q4 last year. Entresto made explosive growth demonstrating its superior efficacy in heart failure with reduced ejection fraction (HFrEF). Entresto replaced the ACE or ARB inhibitors that had been mainly used in these patients. In HFpEF, no suitable treatment exists other than Entresto. Entresto may be used in patients with a left ventricular ejection fraction of 40% or higher to 60% (below normal level). Based on the evidence, the Korean Society of Heart Failure (KSHF) recommended Entresto as a priority treatment in HFrEF, and as a Class IIa, Level of Evidence B in heart failure with mildly reduced EF and heart failure with preserved ejection fraction in the newly revised clinical practice guidelines last year. Recently, Novartis released large-scale real-world trial data on Entresto that was conducted on Korean patients, increasing evidence on the efficacy and safety of the drug. Results of the study that was conducted on a total of 600 patients from 2017 to 2019 showed that patients first started treatment with the initial 50-100 mg bid dose and maintained or stably increased the dose for 12 and reached target dose. The trial results addressed the concerns on how the target dose of Entresto was difficult to administer due to concerns over hypotension. Of the total patients, about 40% maintained their dose of Entresto, and 42% stably increased their dose. SGLT-2 inhibitors, which were previously used as diabetes drugs, had expanded their scope to treating heart failure. Although new drugs with new mechanisms of action have also been introduced to the market, Entresto's growth is expected to continue for the time being as newly introduced drugs have a different mechanism of action, and various attempts at its combined use with other class drugs are expected to be made. Domestic companies have been continuing their attempts to challenge Entresto that had emerged as a blockbuster drug. Domestic pharmaceutical companies, starting with Hanmi Pharmaceutical, followed by Chong Kun Dang, Samjin Pharm, Hana Pharm, and Ahn-Gook Pharmaceutical, filed suits to avoid all four patents related on Entresto. Last year, Hanmi Pharmaceutical was the first to succeed in avoiding all 4 patents related to Entresto. Since then, 9 more companies have succeeded in avoiding the patents. In other words, the generic companies have all won the first trial. Novartis appealed to the results of the first trial, and the second trial is currently in progress.
- Company
- Huonslab is speeding up the development of Prolia biosimilar
- by Lee, Seok-Jun Feb 08, 2023 05:53am
- Huonslab announced on the 7th that it has confirmed that the HLB3-013 biosimilar under development is equally effective in non-clinical animal efficacy tests compared to the original Prolia. This is the result of an osteoporosis-causing model mouse at an overseas CRO institution (BioMedCore, Greece). When the original and HLB3-013 were treated equally, the effect of inhibiting osteoporosis symptoms was confirmed in various factors (average volume, density, separation, and external bone thickness of the femur). The same effect was shown at the same concentration of the test group compared to Prolia (3 mg/kg, 10 mg/kg). Prolia's mechanism of action is a drug that prevents bone destruction by binding to RANKL, an essential protein for bone-destroying osteoblasts, to suppress the formation, function, and survival of osteoblasts. Prolia is a biopharmaceutical product with improved convenience and persistence that lasts for six months with the first dose. With this effect, it is used in treatment for increasing bone density in osteoporosis patients. The patent is about to expire in 2025. Prolia's global sales in 2022 recorded about 4.55 trillion won (about $3.6 billion) and domestic sales about 100 billion won. Yoon Sung-tae, CEO of Huonslab, said, "As we have confirmed the same effect in animals, we will launch the Prolia biosimilar by conducting follow-up studies on non-clinical toxicity and clinical trials." Huonslab is a company that develops new biological drugs and biosimilars. It is developing Prolia biosimilar for the third time in Korea.
- Company
- Prescription of Celltrion’s Takeda drugs fall for 2 yrs
- by Kim, Jin-Gu Feb 08, 2023 05:53am
- Prescription performance of the 3 major chronic disease treatments that Celltrion Pharm acquired from Takeda Pharmaceutical had fallen for 2 consecutive years since their acquisition. The ‘Nesina’ series, which account for the most proportion of sales among the acquired products, recorded KRW 28.2 billion in sales last year, recording a downward trend for 3 consecutive years since 2020. Sales of the other diabetes treatment ‘Actos’ series and the hypertension treatment ‘Edarbi’ series have also shown sluggish sales in terms of prescription performance over the past 2 years. According to the market research institution UBIST on the 8th, the total prescription amount of the 3 major chronic disease treatments that Celltrion acquired from Takeda Pharmaceutical was KRW 65.4 billion last year. This is a 5% decrease from the KRW 68.9 billion recorded by the same drugs in 2021. In June 2020, Celltrion signed an agreement with Takeda Pharmaceutical to acquire the rights of 18 prescription drugs and OTCs sold by Takeda’s Primary Care Business Unit in the Asia Pacific region for a total of USD 278.3 million (KRW 307.4 billion). Under the deal, the company acquired the diabetes treatment Nesina Actos, the hypertension treatment Edarbi, and OTCs Whituben, Albothyl, etc. The acquisition process was completed in December of the same year, and work to switch the domestic marketing authorization license had been ongoing until January last year. The products are now being sold by Celltrion in Korea. The decrease in sales was most significant in the sales of the Nesina series, the DPP-4 inhibitor class diabetes treatments. Total sales of Nesina, Nesina Met, and Nesina Act recorded KRW 28.2 billion last year. Ever since their sales peaked at KRW 35.9 billion in 2019, sales steadily declined to KRW 33.4 billion in 2020, then KRW 31.4 billion in 2021. In particular, sales fell below KRW 30 billion for the first time in 6 years since 2016 last year. In the case of the Nesina series, their prescriptions have been on a decline even before the drug was acquired by Celltrion due to fierce competition in the DPP-4 inhibitor class diabetes treatment market. In addition, the release of generic versions of its competitor Galvus and Tenelia further decreased the influence of Nesina in the market. The TZD class antidiabetic Actos series and the ARB class hypertension treatment Edarbi series had also shown a slowdown in sales recently. The total prescription amount of Actos, Actos Med, and ActosRyl was KRW 25.9 billion, which was a 3% increase from KRW 25.2 billion in 2020. However, the amount had decreased by 2% from KRW 26.6. billion in 2021. Total prescriptions of Edarbi and Edarbi klo had increased by 3% in the past 2 years from KRW 10.8 billion in 2020 to KRW 11.2 billion last year. The combined prescription amount of the three product groups rose steadily from KRW 62.9 billion in 2018 to KRW 69.5 billion in 2020. However, sales then fell to KRW 68.9 billion in 2021, then to KRW 65.4 billion last year. After Celltrion acquired the products, sales performance of the Edarbi and Actos series had improved slightly, but as the performance of the Nesina series, which accounted for the largest portion of sales among the acquired products decreased significantly, this is analyzed to have led to the decrease in the total prescription amount. In the case of the OTCs Whituben and Albothyl, their sales data has not been compiled yet. However, in the case of Whituben, sales are said to have increased twofold compared to the previous year due to the increase in demand for cold medicines following the rapid increase in confirmed cases of COVID-19 last year. Sales of the Whituben series in 2021 had been KRW 2.5 billion.
- Company
- The first reverse growth of NOAC worth 230 billion won
- by Jung, Sae-Im Feb 08, 2023 05:53am
- Eliquis·Pradaxa·Xarelto·Eliquis The NOAC market, which is worth 230 billion won, fell for the first time last year. This is because the generic market for some items was opened and drug prices were cut. Generics, which competed with the original "Xarelto," secured a market worth 9 billion won last year. According to Ubist, a pharmaceutical market research firm on the 8th, the size of the outpatient prescription market in the NOAC market last year was 227.6 billion won, down 1.8% from 231.8 billion won the previous year. NOAC has attracted attention as a drug that has a lower risk of bleeding side effects than warfarin, a conventional anticoagulant, and has a great thromboembolic effect. A total of four original products are on sale. Since the early 2010s, they have replaced warfarin and gained influence in the prescription field. The NOAC market, which had been increasing every year, saw its annual prescription reverse growth for the first time in 2022. With the emergence of generics of some items, the original drug price cut was made, and it entered a downward phase. The representative one is Bayer's "Xarelto." Last year, Xarelto's outpatient prescription amount was 46.8 billion won, down 22% from 59.6 billion won the previous year. Since its launch, Xarelto prescription solutions, which have continued to grow, have turned downward since last year. The biggest blow is the original drug price due to the generic salary registration. As of August 22 last year, the Ministry of Health and Welfare cut the drug price of all doses of Xarelto (2.5·10·15·20mg) by 30%. This is because the Seoul High Court sided with the Ministry of Health and Welfare in a lawsuit filed by Bayer against the Ministry of Health and Welfare to cancel the Xarelto drug price cut. The Xarelto price was scheduled to be lowered in May 2021, when generic was first listed, but the execution was suspended until the original ruling because Bayer filed a lawsuit that the drug price cut was unfair, saying that Generic was released before the patent expired. The ruling was made after about a year and two months, and the drug price cut was finally confirmed. Xarelto's quarterly prescription, which was between 14 billion won and 15 billion won, fell sharply to 11 billion won in the third quarter. In the fourth quarter, it was 7.4 billion won, which is half the level before the drug price cut. Compared to 2020, Xarelto's prescription in the second half of last year lost 40%. The decline is expected to be steeper as additional Xarelto drug price cuts are expected this year. The government will add the original drug price to 53.55% for the first time when generic is listed, and 70% for one year after adjusting it to 53.55%. As a result, Xarelto, which was cut by only 30% last year, is expected to be cut by 23.5% to 23.6% this year. The influence of Xarelto generic is also growing. Last year, Xarelto generic products received 9 billion won in outpatient prescriptions, more than five times higher than the 1.6 billion won in the previous year. Chong Kun Dang (2.9 billion won), Hanmi Pharm (1.5 billion won), and Samjin Pharm (1 billion won) are driving the growth of the generic market. ◆Lixiana and Eliquis increase without generic penetration, 160 Billion-scale Lixiana, the No. 1 in this market, raised its prescription amount by 89 billion won last year. This is an increase of 5% compared to the previous year. Lixiana is the latest NOAC formulation to enter the market. There is a five-year difference from other drugs. Despite being generic, Lixiana succeeded in reversing in 2019 by accumulating data through direct comparative studies with other drugs. Analysts say that aggressive sales strategies with domestic companies also affected rapid growth. Lixiana, which was 4.8 billion won in 2016, expanded its size from 20.9 billion won in 2017 to 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021. As of last year, Lixiana accounted for 41% of the original NOAC market. BMS's Eliquis ranked second in the NOAC market. Equis' prescription amount last year was 70.6 billion won, an 8% increase from the previous year. The recent increase in Eliquis' sales is largely due to the withdrawal of generics. Eliquis' growth slowed in June 2019 as it faced competition with generics. Generic companies, which won the case until the second trial, preemptively released generic, and annual prescriptions rose by nearly 10 billion won in 2020. During this period, Eliquis was 50.6 billion won in 2019 and 55 billion won in 2020. Eliquis growth, which increased by 10 billion won every year, slowed down. However, in April 2021, the Supreme Court reversed the previous ruling in the patent lawsuit and sided with BMS, taking a new turn. Immediately after the ruling, the generics withdrew from the market en masse. This is because BMS announced a claim for damages due to patent infringement. The Mayor of Eliquis generic, which was 1.2 billion won in 2019 and 9.4 billion won in 2020, shrank to 5.4 billion won in 2021, when the Supreme Court ruled. Last year, the prescription amount was 0 won as the generic benefit was deleted and all distribution inventory was exhausted. Along with this, Eliquis' prescription amount, which had slowed down, recovered to 65.2 billion won in 2021, expanding by 10 billion won again. Last year, it surpassed 70 billion won. Generics that lost the lawsuit can only sell their products after September next year. ◆Pradaxa's sales have been on the decline for 5 years Sales of another NOAC, Pradaxa of Beringer Ingelheim, have been on the decline for the fifth consecutive year. Pradaxa's prescription amount last year was 12.2 billion won, down 20% from 15.2 billion won in 2020. Unlike other formulations, Pradaxa, which expanded its size in 2017, failed to exceed 20 billion won and turned downward. Pradaxa's sales, which were 21.6 billion won in 2017, showed a clear decline to 19.6 billion won in 2018, 18.7 billion won in 2019, and 16.5 billion won in 2019. Pradaxa, which has been pushed back from the competition with NOAC Original, is also out of the interest of generics. According to the Ministry of Food and Drug Safety, 10 domestic companies were licensed for Pradaxa Generics in 2018, but none of them have been released on the market. It seems that it is meaningless to compete in the Pradaxa market, which is only 10 billion won.
