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- 2026-04-15 18:24:24
- Company
- MSD received administrative disposition for packaging
- by Whang, hyung-woo Jan 12, 2021 06:19am
- MSD Korea has been subject to administrative disposition for violating the provisions of supplying small packages. However, it was confirmed that they were looking for a way through the exception. Considering the characteristics of taking 2 tablets a day, it applied for relief saying that it had to admit an exception to the packaging of 60 tablets. However, there are many opinions that time is imminent as the import suspension measures for the item will proceed from next week immediately. #The MFDS imposed administrative measures to suspend manufacturing and import operations for pharmaceutical companies that violate the regulations on supplying small quantities of medicines in small quantities. MSD Korea was found to violate Article 42 of the Pharmaceutical Affairs Law due to the lack of standards for supplying small quantities of medicines in 2019, two items, Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized). According to the supply regulations related to package packaging for pharmaceuticals, manufacturers must supply 10% of the annual manufacturing/import volume for each item. However, if there is little data or product demand on inventory and disposal, the ratio can be set lower than 10%. In the case of MSD, it violated the regulation of 30 tablets packaging. Accordingly, the drug cannot be imported into Korea from January 15 to February 14. In the case of a violation of the current regulations on supplying small-sized packaging units, an administrative disposition for one month of suspension of the manufacturing business is applied, and in the case of the second violation, a three-month suspension of manufacturing business is imposed. However, MSD is planning to receive an exception to the regulation of the small package as both Isentress (Raltegravir) and Isentress HD (Raltegravir, potassium micronized) have characteristics of dosage. The dosage of Isentress published on the MSD official website is 400mg twice a day in combination with other antiretroviral drugs for the treatment of adult patients infected with HIV-1 on an adult basis. According to the current regulations, the two products must be packaged in a small package of 30 tablets or less, but the related product is characterized by taking 2 tablets a day, so it will be recognized that there is only one packaging unit of 60 tablets. MSD noted that it is in the process of being reviewed with relevant data submitted to the MFDS in order to obtain an exception. An MSD official said, "We have submitted data to receive exceptions considering the dosage of the product. The package of 60 tablets should be accepted as an exception considering the dosage characteristics of the drug." However, the time is imminent in that the administrative disposition procedure will start from the 15th, apart from the review of the MFDS. An MSD official said, "As a result of the current analysis, the problem in supply and demand of medicines due to import suspension is expected to be negligible."
- Policy
- Breaking down MOHW 2021 action plan for NHI Master Plan
- by Kim, Jung-Ju Jan 12, 2021 06:19am
- The drug reimbursement benefit would be improved throughout chronic disease treatment this year, centering hepatitis B and C virus treatment and antidiabetic combination drugs. The already listed drug reimbursement reevaluation would be enforced from the latter half of the year, when the subjects are decided in the first half of the year. Moreover, the external reference pricing criteria, generic substitution incentive, also known as Rewards for Saving Drug Expenditure (RSDE), would be amended within this year. South Korea’s Ministry of Health and Welfare (MOHW) is to unfold the ‘2021 Action Plan for the First National Health Insurance (NHI) Master Plan’ as scheduled. These plans would follow the yearly flow of innovative NHI coverage enhancement initiative and the reimbursement quality and finance management programs. Pharmaceutical coverage enhancement initiative—granting reimbursement on non-reimbursed drugs The ‘Reimbursement Provision on Non-reimbursed Drug’ program that enhances coverage while keeping the positive listing system, would expand on chronic disease treatment as it did on musculoskeletal and pain clinic medication and anticancer treatment (adjuvant drug) last year. So far, the government completed newly listing total 60 items (22 anticancer treatments and 38 general drugs) with high social and clinical demand, originally categorized as non-reimbursed drug. An immunotherapy Tecentriq (January 2018), a multiple myeloma treatment Kyprolis (February 2018), a renal cell carcinoma treatment Cabometyx (February 2019) and an immunotherapy Imfinzi (April 2020) are now all covered by NHI. General drugs, such as hepatitis C virus treatment Mavyret (June 2018), a new drug for spinal muscular atrophy (SMA) Spinraza (April 2019), a severe atopic dermatitis treatment Dupixent (January 2020), and a hemophilia treatment Hemlibra (May 2020), were also listed for reimbursement. With the initiative to cover the listed drugs in non-reimbursed criteria, the coverage was applied on total 124 items, consisting of 15 anticancer treatment and 109 general drugs. A chronic lymphocytic leukemia treatment Imbruvica (April 2018), a breast cancer treatment Perjeta (May 2019), a hepatocellular carcinoma treatment Nexavar (January 2020), an acute lymphoblastic leukemia treatment Blincyto (April 2020) and a parenteral iron therapy Venoferrum (May 2020) received the NHI benefit. The drug coverage expansion program is to continue this year as well, concentrating on non-reimbursed treatments for chronic disease, i.e. hepatitis B and C virus treatments and antidiabetic treatment. The government plans to revise the pharmacoeconomic evaluation guideline within the first quarter, and reflect the external reference pricing changes on regulation by the second half of the year. The government expects the patients’ treatment access would be improved and their financial burden would be lessened by the new coverage on drugs with high social and clinical demand. NHI sustainability—reevaluating listed drugs The government has been reassessing the reimbursement adequacy and feasibility on medical service, pharmaceutical, and medical treatment material, in the said sequential order. In November 2019, Drug Post-listing Evaluation Subcommittee under the Drug Reimbursement Evaluation Committee was formed and selected choline alfoscerate to reevaluate the reimbursement from February through July and changed the benefit to selective reimbursement (copayment rate 80 percent) for using the drug in treating conditions other than dementia. Also, the government is to initiate the reevaluation program this year after finalizing the process and revising the weighted drug pricing system since last February. In particular, by integrating the current weighted pricings—‘one year plus infinite (number of companies supplying same substance drug less than three)’ for synthetics, and ‘two years plus one year (number of same substance drug suppliers less than three)’ for biologics—the government is to apply ‘one year plus two years (number of same substance drug suppliers less than three)’ for both synthetics and biologics and to extend two years after deliberation. The weighted pricing reevaluation would be conducted within the first half of the year, and the actual full on reevaluation would start from the latter half of the year after selecting subject drugs with uncertainty. The government anticipates the reevaluation to create a foundation for essential drug-centered coverage expansion. NHI sustainability—improved management of pharmaceutical expense To better manage the pharmaceutical expense, the government has been compiling long and mid-term drug reimbursement strategy so far based on the revised volume-pricing linkage system. First, the RSDE program improvements would be established to control the drug use volume by referring to the previous researches. The government would review the plan in the first quarter, put together the improvements and finalize them by the end of the year. As for pharmaceutical expense control, the detailed drug reimbursement-deciding principles and listing prioritization would be reviewed by the third quarter and finalized within the fourth quarter. The final adjustment would be decided and finalized in the latter half of the year, after thoroughly analyzing the external reference pricing with the current pricing range for each chronic and senile disorder drugs in South Korea.
- Company
- HK inno.N wins big in huge shift of global vaccine licenses
- by Kim, Jin-Gu Jan 11, 2021 06:11am
- Started from late last year, the massive shift in South Korean market sales rights over global vaccines has come to an end. Global companies like MSD, GSK and Sanofi Pasteur, and South Korean companies like GC Pharma, SK Bioscience, HK inno.N, Yuhan Corporation and Handok were involved in the mass migration of the businesses. The industry sees that HK inno.N took the biggest piece of the pie during the process. SK Bioscience letting go of one deal and taking another was also evaluated to have defended its position successfully. Also Handok was able to maintain its deals. However, GC Pharma and Yuhan are to minimize their loss of losing existing deals by concentrating on other items. ◆HK inno.N embraces deals worth 140 billion won as MSD entrusts all seven vaccines On Jan. 6, SK Bioscience announced it inked the co-marketing contract over five types of GSK vaccines. The announcement marked the end of global vaccine sales license migration in the South Korean market started since late last year. HK inno.N is supposedly the biggest winner of the shift that lasted three months. The Korean company signed the co-marketing and distribution contracts for seven of MSD vaccines in last November. Initially, GC Pharma had three of the deals and SK Bioscience had four of them, but all of them were transferred to HK inno.N. The pharmaceutical market research firm IQVIA says the seven MSD vaccine generated 141.5 billion won in last one year (Q4 2019 through Q3 2020). As a result, HK inno.N is to make 140 billion won more from this year on. ◆SK to fill up the 30 billion won loss from MSD vaccine deals with GSK vaccines The industry views SK Bioscience has done a good job compensating the damage of losing four MSD vaccines with five new GSK vaccine deals. Although HK inno.N took over four MSD vaccine contracts from SK Bioscience in last November, the company actually nabbed five of GSK vaccine deals early this year. When the previous four vaccines used to make 31.4 billion won annually, the new five vaccines would make 26.2 billion won. The simple math may indicate an immediate loss, but the increase in vaccine types could mean potential growth through strengthened sales strategy. Also the five adult vaccines by GSK could create synergy effect with the Korean company’s vaccines, Sky Zoster (varicella virus vaccine) and Sky Cellflu (influenza vaccine). ◆Handok and Sanofi extend co-promotion contract valued at 20 billion won annually Handok was able to successfully defend all existing deals with Sanofi Pasteur. In May 2019, Handok sealed the deals with Sanofi Pasteur on co-promoting six vaccines. The deals expired late last year, but the two companies have agreed to extend the terms before the expiration. The details of the extension have not been disclosed. The six vaccines have generated 21.6 billion won in last 12 months. Handok is to keep the annual income for this year. ◆Yuhan and GC lose sales licenses in South Korea, “Concentrating more on our own" Meanwhile, Yuhan Corporation and GC Pharm ended their vaccine deals with GSK and MSD during their contract extension negotiation. The damage of losing Zostavax and Gardasil would cost GC Pharma 110 billion won a year. Yuhan would also miss out on 20 billion won a year due to the terminated contract. The two companies plan to focus on their own products to minimize the loss. Specifically, Yuhan’s focal point would be on a lung cancer treatment lazertinib expected to receive conditional approval in the first quarter. The company has already hired anticancer sales people for the new business. GC Pharma is to also keep itself busy with its own influenza and varicella virus vaccine sales. Apparently, GC Flu’s last year sales have improved significantly in the third quarter due to COVID-19. Also the company’s varicella virus vaccine line-up has been updated to a new generation. Instead of the existing Suduvax, the new Barycela would be sold from this year. A pharmaceutical industry insider noted, “The companies would probably integrate the previously dispersed sales forces for their own products. The sales gap would not be that drastic.”
- Policy
- 22 generics for Atozet by Chong Kun Dang were approved
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- MSD’s Atozet, generics of 22 companies were approved following Chong Kun DangThe products of 22 companies for hyperlipidemia (Ezetimibe/Atorvastatin) consigned by Chong Kun Dang were approved on the 8th. As a result, 20 generisc within the same ingredient were approved, and the next drug price application for the same drug product was reduced to the lowest price. This is because of the stepped drug price system that has been in effect since July of last year. On the 8th, the MFDS approved 22 companies' Ezetimibe/Atorvastatin combination. The companies are Kyongbo, Dongkoo Bio, Celltrion, Yooyoung, YuYu, Kukje, DongKook, Boryung, Samjin, SCD, Ahn-gook, Arlico, Alvogen Korea, SK Chemicals, HK inno.N, Wooridul, Reyon, Jinyang, Hana, Korea United, Korea Prime, and Hutecs. It also includes Dongkoo Bio, which has completed the development of generic and recruited contractors. Chong Kun Dang was approved in October as a drug for data-based re-evaluation through its own development of Ezetimibe/Atorvastatin. MSD Korea's original Atozet was approved before the expiration of PMS. Atozet's PMS will end on the 22nd of this month. Chong Kun Dang also recruited a commissioned generic company. Considering the drug price, more than 20 companies were recruited. This is because if it is less than 20, the next licensed generic drug can also receive the highest price within 20. Chong Kun Dang and consigned pharmaceutical companies promised that Chong Kun Dang would recruit 20 generic companies. In the current drug price system, if more than 20 active ingredients are listed, the upper limit of the newly listed item will drop to 85% of the existing lowest price. Some generic companies said they would file a complaint with the Fair Trade Commission, claiming that Chong Kun Dang and consignment manufacturers are fixing drug prices. They said that if the related companies voluntarily report, they will be excluded from the complaint. However, there was no company that voluntarily reported. The issue of preemption of drug prices through consignment of a drug for data-based re-evaluation led to controversy over revision of the law. Some lawmakers argued that there is a need to limit the number of drugs for data-based re-evaluation as well as generics. Jeong-sook Seo, a member of People Power Party Rep also proposed a related bill. However, small and medium-sized pharmaceutical companies strongly oppose it, and the MFDS, the ministry in charge, is also cautious about this. Therefore, the revision of the law is not expected to be easy. Chong Kun Dang changed the name of the previously approved product. The first licensed product name is used by Kyongbo. Lipilou is a blockbuster hyperlipidemia treatment sold by Chong Kun Dang. The use of the company's product name is a strategy to increase the awareness of the new product to existing customers. Chong Kun Dang's active marketing is expected. Chong Kun Dang is also jointly selling the original Atozet, and it is noteworthy whether there will be any changes due to the release of Chong Kun Dang's new product name.
- Policy
- Plasma treatment was completed in Phase II clinical trial
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Kwon Jun-wook, the 2nd vice-president of the Central Disease Control HeadquartersThe government confirmed that the patient administration of the clinical II trial of a domestically developed blood system drug has been completed. As in the case of Celltrion's antibody treatment, the application for Conditional Marketing Authorization (CMA) is imminent. Kwon Jun-wook, the 2nd vice-president of the Central Disease Control Headquarters said at a briefing on the current status of COVID-19 in Korea on the 7th, "Phase II clinical trials have been conducted at 13 medical institutions in relation to the clinical trials of blood system drugs currently being developed in Korea. In the situation where the medication was completed to 64 patients.” In this regard, a total of 6,554 people have registered plasma donation, and 4,139 people have actually completed plasma donation. He emphasized that on December 24 of last year, in the update of the COVID-19 treatment guidelines, he recommended the use of Remdesivir among antiviral drugs and Dexamethasone among immunomodulators as a treatment for the elderly, underlying disease and severe patients. He added, "In the case of malaria treatments such as Chloroquine single or combined therapy, it is not recommended because it does not appear to be effective against COVID-19, and HIV protease inhibitors such as Kaletra are also not recommended." Recently, treatments such as Chloroquine seem to have been mentioned to correct this as fake news about the effect of COVID-19 spread through SNS. Meanwhile, Remdesivir has been prescribed to 3,108 confirmed patients in 105 hospitals.
- Policy
- Adenovirus for AZ vaccine, Sinopharm uses inactivated virus
- by Lee, Tak-Sun Jan 11, 2021 06:10am
- Diverse types of COVID-19 vaccines are currently in development. Pfizer and Moderna’s vaccine candidates are based on RNA, when AstraZeneca’s is a virus vector and Korean-based SK Bioscience’ is a recombinant vaccine. These types of vaccine have their respective strengths and weaknesses. Some types have been commercialized already, but mRNA vaccine has never been commercialized, making the COVID-19 vaccine the first product. On Jan. 7, South Korea’s Ministry of Food and Drug Safety (MFDS) explained about the different types of COVID-19 in development and their mechanisms. The international effort to promptly seek COVID-19 vaccine has pushed pharmaceutical companies to explore a variety of vaccine platform technologies, including virus vector vaccine, mRNA vaccine, recombinant DNA vaccine and inactivated vaccine. #AstraZeneca and Janssen take virus vector vaccine, when Pfizer and Moderna take mRNA vaccine A virus vector vaccine injects adenovirus harmless via virus vector to human body to generate the antigen in the body inducing the adequate immune response. AstraZeneca and Janssen, already signed the procurement deal with South Korea, use the mechanism for their vaccines. The AstraZeneca’s vaccine uses adenovirus that only infects chimpanzees. Compared to mRNA vaccine, the virus vector vaccine is considered to be more stable around heat. But the vaccine type requires cold chain maintained at 4 degrees Celsius as it uses a live adenovirus. So far, Janssen’s Ebola vaccine using the mechanism was the only vaccine approved to market. The U.K. health authority has approved AstraZeneca’s vaccine as of Dec. 30, 2020 for an emergency use, whereas European Medicines Agency (EMA) is reportedly conducting an evaluation from October last year. In South Korea, MFDS is currently reviewing the vaccine applied for approval on Jan. 4, 2021. Janssen’s (Johnson and Johnson) investigational vaccine is conducting a Phase III clinical trial since September 2020. The vaccine has already requested for evaluation in South Korea (Dec. 22, 2020) with the non-clinical and quality relevant evidences. A Korean company Cellid’s candidate vaccine is in process of Phase 1/2 clinical study. In development by Pfizer and Moderna, mRNA vaccine injects antigen gene as a messenger RNA form to generate antigen protein that instigates immune response. The type of vaccine is to be introduced to South Korea later this year. Although the particular vaccine type can be mass produced with fast manufacturing speed, maintaining the stability is extremely difficult with the RNA easily broken down by ribonuclease. Accordingly, the vaccine requires cold chain with temperature kept at around minus 20 degrees Celsius or minus 75 degrees Celsius. And it would be the first time for the type of vaccine to be commercialized. RNA, or ribonucleic acid, is one of two nucleic acids in a cell, which carries genetic information and adjusts genetic expression. Currently, the U.K (Dec. 2, 2020), the U.S. (Dec. 11, 2020) and Canada (Dec. 9, 2020) have granted an emergency approval on Pfizer’s vaccine, whereas Switzerland (Dec. 19, 2020) and EU (Dec. 21, 2020) have conditionally approved the vaccine use. MFDS elaborated the ministry is positive about the use of Pfizer’s vaccine as it is widely used all around the world, and even the World Health Organization (WHO) also granted approval on the emergency use (Dec. 31, 2020). The vaccine has applied for evaluation on its non-clinical and clinical data on Dec. 18 last year. Moderna’s vaccine has been approved for emergency use in the U.S. (Dec. 18, 2020) and conditionally cleared by EU (Jan. 6, 2021). The vaccine has not started the review and approval process in South Korea. From South Korea, Genexine and Gene One Life Science are respectively developing DNA vaccine, similar to the mRNA vaccine. DNA, or deoxyribonucleic acid, is one of two nucleic acids in a cell, which archives and conserves genetic information. Novavax and SK working on recombinant vaccine already used for HBV and HPV vaccine Recombinant vaccine directly injects antigen protein made from recombinant DNA technology to induce immune response, which is one of the most commonly used vaccine platforms. Because the recombinant antigen protein could be insufficient for the full immune response, generally an administration route with vaccine adjuvant is needed. But it is known to be the highly safe vaccine for it has been used throughout the time. Hepatitis B virus vaccine and HPV vaccine use the platform, for instance. Novavax is using the platform for a COVID-19 vaccine with an ongoing Phase III clinical trial started from September last year. Regardless, it has not been approved by any foreign health authority. In South Korea, SK Bioscience is running a Phase 1/2 trial for the vaccine candidate. Inactivated vaccine is a traditional platform of vaccine that triggers immune response by injecting antigen made of killed virus. A number of vaccines are made with the technology. It can be rapidly developed when the infectious virus is collected, and the manufacturing process is comparatively simple and it has an advantage of having outstanding neutralizing antibody. However, for the COVID-19, the vaccine would require a manufacturing facility certified over Biosafety Level 3 (BL3). Biosafety level indicates the level of a facility to safely handle potentially lethal infectious pathogen and depending on the level of the lethal disease, the facility is given a level ranging from BL1 to BL4. Hepatitis A vaccine, injected polio vaccine and Japanese encephalitis vaccine use the inactivated virus platform. A Chinese-based Sinopharm has developed COVID-19 vaccine with the technology green lit for use on July 22, 2020 in China. And according to WHO’s COVID-19 vaccine candidate update report, CanSino Bio (virus vector vaccine) and Gamaleya (virus vector vaccine) are also working on other types of COVID-19 vaccines as well. Considering the public’s heightened interest on COVID-19 vaccine, MFDS stated it would constantly update the vaccine’s efficacy and safety information, and focus on creating an environment for the people to get inoculated with no concern. Moreover, the ministry official added they would do their best for the people to use the safe vaccine by strictly reviewing and managing safety and efficacy of the approved vaccine.
- Company
- Allergan Korea names Kim Sook-hyun as new CEO
- by Jan 11, 2021 06:10am
- New CEO, Kim Sook-hyun Allergan Korea Aesthetic-AbbVie Company said it has selected Kim Sook-hyun as the new CEO as of Jan. 1 She is a global healthcare professional with 22 years of experience in Korea, Asia, and headquarters receiving an MBA at Kelley School of Business after graduating from industrial pharmacy at Seoul National University. She joined Abbott Korea in 2006, as the Humira Business Unit Manager and served as the director of Commercial Business Divisions in Japan and Asia Pacific in Singapore in 2011. In 2015, she took over the head of the Immunization Division at AbbVie, Korea. Since 2018, she has been contributing to the establishment of immune drug brand strategy and organizational change by serving as the global marketing and commercial division of the AbbVie headquarters, as well as the global marketing director for new business markets in Japan and Australia. She said, "I am pleased to be with Allergan Aesthetics for the growth and development of Korean business, which has led the global innovation in the medical aesthetics field, and I feel a heavy responsibility at the same time. Based on the experience accumulated in the pharmaceutical market, we will do our best to provide cutting-edge medical esthetic solutions to meet the expectations and demands of the rapidly evolving Korean medical beauty market."
- Opinion
- [Reproter's View] Have you forgotten what the MFDS does?
- by Lee, Tak-Sun Jan 08, 2021 06:21am
- It was expected that the politics and media would put pressure on the introduction of COVID-19 vaccine, but it is too blatant. They only emphasize rapid introduction forgetting the role of the MFDS in verifying the safety and effectiveness of vaccines. From the time President Trump pressed the US FDA, the independence of the MFDS was expected to be affected. In recent years, the European EMA is also under pressure from each country, and it is in a situation where it is advancing the recruitment of the review committee to approve COVID-19 vaccine, so it is obvious that the drug regulatory authorities in each country are suffering. The MFDS was presented with a deadline altogether. In foreign countries, after urgently approving COVID-19 vaccine, the deadline was officialized in February as politics and the media urged rapid introduction every day. The MFDS seems to have to approve one company’s COVID-19 vaccine after completing the review before February. It is understandable that the current situation is not good, so it is possible to introduce it as early as possible, and this can be considered a special case. However, there was no MFDS in the process of discussion. They don't seem to know that the vaccine can only be approved by the MFDS through systematic screening. No confidence in the regulatory authorities was shown. Some media have ignored the MFDS, asking if the MFDS can review and approve vaccines that are not approved by the US FDA. These reports only dampen the will of the MFDS, which is showing its willingness to independently screen by abolishing the obligation to submit CPP (manufacturing and sales certificates in importing countries). It is difficult to apply the same situation in the UK and the United States, which initially approved COVID-19 vaccine. In that country, the vaccine has undergone clinical trials and has been reviewed through a preliminary review. Nevertheless, the FDA was the first to grant EUA for the vaccine. Chloroquine, COVID-19 treatment that was urgently approved by the FDA, was also withdrawn. As such, emergency approval drugs cannot be fully guaranteed for efficacy and safety like formal approval. Korea does not have an Emergency Use Authorization System (EUA). In case of an emergency, there is a special import or special manufacturing system, but it is difficult in situations where there is no data to verify at all, such as a vaccine developed overseas for COVID-19. This is because clinical trials have never actually been conducted in Korea. It is impossible to get vaccination while skipping the MFDS. Nevertheless, some politicians and the media are misleading as if they could inoculate the people immediately after signing a supply contract. In the future, the MFDS should not be condemned even if the MFDS is delayed in approving COVID-19 vaccine. If the MFDS is pressed as it is now, drug approval is difficult to ensure transparency and national security. Now it depends on the MFDS. Let's first trust the MFDS so that COVID-19 vaccine can be thoroughly verified and brought in.
- Company
- 51 Jardiance patent-challenging generics released in 4 years
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Jardiance Six more pharmaceutical companies are to evade the patents on Boehringer Ingelheim Korea’s antidiabetic sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin). As a result, total 51 companies would be able to avoid charges on infringing the product’s patent. The pharmaceutical industry source reported on Jan. 7 that the Intellectual Property Trial and Appeal Board approved of Kolmar Korea and Kolmar Pharma’s request to negatively confirm the scope of Boehringer Ingelheim Jardiance’ crystalline form patent on Jan. 5. And on Jan. 6, the Board also accepted the request filed by Kuhnil Pharm, Penmix, GL Pharma and Kyongbo Pharmaceutical. Now there are two outstanding cases left without a ruling, yet. The industry anticipates the generic makers—Korea United Pharm and Korea Biochem Pharm—would win the case challenging the Jardiance’ crystalline form patent. If they were to win, total 53 companies would be able to overcome Jardiance patent barrier. Since Chong Kun Dang first evaded the patent in May 2019, other generic companies have followed the footstep and challenged the patent. The generic companies mostly won the cases. The challenged patent is to expire in December 2026. The generic companies that successfully challenged the original’s patent may launch their follow-on drugs after March 2025, when the product patent expires. In four years time, 50 companies could release generics to the market all at once.
- Company
- Korean-made novel drug Kanarb keeps on evolving
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Kanarb Boryung Pharmaceutical’s star Kanarb (fimasartan) has added a new indication after a decade. Now the drug is indicated to reduce proteinuria in a hypertensive diabetic patient. In the highly saturated market for angiotensin II receptor blocker (ARB) for hypertension, Kanarb has found a new weapon to break through the stagnated growth. Besides the indication expansion, Boryung Pharmaceutical is also seeking for Kanarb combination drug, adding a variety of doses and expanding user age group to drive the prescription growth even after a ten-year anniversary. ◆A third ARB to be indicated to reduce proteinuria confirming superior effect than losartan On Jan. 6, Boryung Pharmaceutical announced the Ministry of Food and Drug Safety (MFDS) newly approved another indication for Kanarb last year. The new indication is to lessen proteinuria in hypertensive type 2 diabetic chronic kidney disease (CKD) patient as an antihypertensive treatment. Now a patient with diabetic CKD can be prescribed with Kanarb. The Korean Society of Hypertension reported 9.02 million patients in South Korea are being treated for their hypertension as of 2018. Among the total patient size, 26 percent, or 2.35 million patients, has a diabetic complication. CKD is the most common complication for a diabetic patient, as two out of ten are suffering from CKD. Because of the medical situation, the healthcare providers primarily prescribe an angiotensin converting enzyme inhibitors (ACE inhibitors) or ARBs to a diabetic CKD patient with hypertension. Prior to Kanarb’s indication expansion, losartan and irbesartan were the only ARB indicated to treat a diabetic CKD. But the new indication has opened a new door for Boryung Pharmaceutical to tap on the potential market of 500,000 patients. The base of the indication expansion, the FANTASTIC study confirmed Kanarb’s effect of reducing proteinuria is significantly better than that of losartan. The Korean company is apparently working on marketing strategy focusing on the indication. ◆Ten years in the market, Kanarb keeps developing doses and combination treatments After ten years, Kanarb was able to add another indication. The drug was first approved by MFDS in September 2010 as a first antihypertensive new drug developed by a Korean company and was released to the market in March 2011. Boryung Pharmaceutical also expanded Kanarb’s doses ranging from 30 mg to 60 mg and 120 mg. Moreover, the company released combination drugs like Lacor (fimasartan plus hydrochlorothiazide) in 2013, and Dukarb (fimasartan plus amlodipine) and Tuvero (fimasartan plus rosuvastatin) in 2016. And in February and September last year, the company also launched Dukaro (fimasartan plus rosuvastatin plus amlodipine) and Akarb (fimasartan plus atorvastatin), respectively, to further diversify the Kanarb line-up. In this year, the company is planning to launch a three-substance combination treatment including fimasartan, amlodipine and hydrochlorothiazide. The drug is now also available for a wider range of age groups as well. The initially stated caution on the label, ‘no record of administering the drug to a patient aged over 70,’ was removed to provide access of the drug to elderly patients aged 71 and over. The constant expansion of the drug use is the source of prescription volume increase. A pharmaceutical market research firm UBIST reported the Kanarb family has generated 94.3 billion won as of November last year. Combining the December prescription volume, it would have exceeded 100 billion won mark. Kanarb single drug alone has generated 45.1 billion won as of last November, showing a 5-percent growth compared to the previous year same time. Although the drug has been in the market for over a decade, its market presence is still growing. Boryung Pharmaceutical could also shoot for the patent term extension with the new indication. Kanarb’s product patent is to expire in February 2023. If the company adds an indication patent, Kanarb’s patent term would be extended by 15 years to 2038. However, the Korean company official mentioned “The term extension is still under review.”
