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- 2026-05-11 21:25:27
- Policy
- Lucentis biosimilar Ameliebou prices cut 24.5% voluntarily
- by Kim, Jung-Ju Feb 22, 2023 05:54am
- Samsung Bioepis lowers the insurance drug price of its sixth biosimilar Ameliebou 10 mg/mL (Ranibizumab) by nearly 25%. It's been two months since the benefit was released. AbbVie Skyrizi PFS and Amgen Korea Repatha are used a lot, so they will conduct PVA with the NHIS and reduce drug prices to 3-6%. According to the industry on the 20th, the Ministry of Health and Welfare plans to revise the list of drug benefits and the upper limit and is pushing to apply it as of the 1st of next month. First of all, there are a total of six drugs that companies will voluntarily cut next month. Samsung Bioepis' biosimilar Ameliebou 10mg/mL will lower its price by 24.5% within two months of its launch. This drug is a biosimilar of Lucentis and is used to inhibit the formation of new blood vessels by binding to Vascular Endothelial Generating Factor (VEGF)-A. Samsung Bioepis signed a domestic distribution and sales contract with Samil Pharmaceutical with the launch of the product and launched it in January. In addition, products containing 20 mg and 10 mg of Yungjin Fluoxetine Cap will be lowered by 53.4% and 38.4%, respectively, while products containing Revlimid's generic, Lenaldo 10 mg and 5 mg of Kwangdong Pharmaceutical will be lowered by 21.1% and 21.2%, respectively. A total of two drugs will be reduced to PVA next month, subject to type "Ka" and "Na", respectively. If looking at the product, AbbVie Skyrizi PFS belongs to the type "Ga" and is on the negotiating list, agreeing to a 6.1% cut. Amgen Korea Repatha PFS will be lowered by 3.7% from next month as a result of PVA negotiations with the corporation.
- Policy
- Chong Kun Dang's Tamivir is listed as the lowest price
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Chong Kun Dang, which has stopped selling the flu treatment "Tamiflu" since this year, was immediately covered by the salary of its generic drug. Chong Kun Dang has been selling Tamiflu for more than a decade in partnership with Roche Korea since 2012 and has not released its own generics with only permission. According to the industry on the 20th, Tamivir 30, 45, and 75mg per Chong Kun Dang will be listed as salary at 524, 907 won, and 1063 won, respectively. Tamivir was approved in December 2009 and was the earliest Korean generic to be approved. Chong Kun Dang has been unable to come to the market since 2012 because it has sold the original Tamiflu capsule in partnership with Roche Korea. Instead, Chong Kun Dang has been selling suspension powder products that are not in the original under the Tamivir brand. At the beginning of the year, Chong Kun Dang sent an official letter to the distribution industry and officially announced the suspension of Tamiflu sales, saying that the salesperson of 75, 45, and 30mg of Tamiflu capsules had been changed from Chong Kun Dang to Roche Korea as of January 6. As a result, the registration of Tamivir is interpreted as a measure following the suspension of sales of Tamiflu by Chong Kun Dang. The Tamivir capsule is currently the lowest price on the same system. In the case of Oseltamivir capsule 30mg, the highest price is 854 won and the lowest price is 790 won, which is 266-330 won more expensive than Chong Kun Dang Tamivir products. 45 mg and 75 mg also differ in price from Chong Kun Dang products. Analysts say that Chong Kun Dang is likely to settle in the market for a short period of time as it has experience in selling Tamiflu and has price competitiveness. As COVID-19 subsides, the flu is on the rise again, and some predict that it could exceed the expected sales in March without supply issues. Attention is focused on how much sales Chong Kun Dang, which changed its product from original to generic, will make in the market.
- Policy
- Revlimid generics also allowed reimb for MDS
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Boryung’s lenalidomide drug Generic versions of Revlimid Cap that contain the same ingredients will be applied reimbursement for the treatment of myelodysplastic syndrome (MDS) in Korea. This is because the generic versions also obtained approval for the indication in October last year. On the 21st, the Health Insurance Review and Assessment Service preannounced plans to apply the above changes when making amendments to the ‘Notices required according to drugs prescribed and administered to cancer patients.’ The amendment will take effect on March 1. The previous reimbursement standards only allowed reimbursement for the original drug, ‘Revlimid Cap,’ among lenalidomide drugs as a treatment for MDS. The standards had been applied since May 2019. Such a decision was made in consideration of the fact that the indications for the same-ingredient drugs that were approved by the MFDS. In the past, only Revlimid had indications related to MDS syndrome approved by the MFDS. However, its generics – Boryung Pharma’s Leblikin Cap, Kwang-dong Pharm’s Lenaldo Cap, and Samyang Holding’s Lenalid Tab – also gained approval for the indication in October last year. This is why HIRA is amending the standards to apply reimbursement to generics as well. Therefore, patients who receive treatment for MDS within the approved indication and reimbursement standards will be granted reimbursement. Meanwhile, the standards for reimbursement of hematopoietic stem cell transplantation will also be amended to allow reimbursement for hematopoietic stem cell transplantations that were conducted without the prior approval process to be allowed reimbursement if they submit other evidentiary that that is equivalent to prior approvals. For this, the notes on the use of blinatumomab monotherapy (Note 6) and inotuzumab ozogamicin monotherapy (note 8) will be changed for acute lymphoblastic leukemia.
- Policy
- Plan to build an information network to normalize the supply
- by Lee, Hye-Kyung Feb 22, 2023 05:54am
- “External environmental factors such as the spread of COVID-19 and the war between Ukraine and Russia have made domestic drug supply and demand abnormal. On January 15, Korea Rare Essential Medicines Center appointed Kim Jin-seok (58, Kyungsung University College of Medicine), former deputy director of the Ministry of Food and Drug Safety, as the 13th director. The KODC, which was established to provide various information on orphan drugs and national essential drugs, is currently managing 511 items of national essential drugs and 315 cases of orphan and essential drugs submitted to the on-site supply and demand monitoring center. A total of 179 items and 14,732 drugs were supplied by the KODC last year, worth 44.2 billion won. Nine free support programs that connect pharmaceutical companies and patients are also in operation, through which 969 new drugs in clinical trials were supplied. Director Kim met with reporters from the Ministry of Food and Drug Safety on the 21st and revealed his ambition to be appointed director of the KODC after 8 months of vacancy. The following is a Q&A from Director Kim. ▶ As the director was appointed after 8 months of vacancy, it seems that there was a setback in the project. "There was a long hiatus for eight months after the former director's resignation. During this period, there was a shortage of medicines around the world due to the outbreak of COVID-19 and monkeypox. Korea was no exception, and monitoring of essential national medicines and supply shortages of medicines occurred. We are aware of the need for a domestic supply of drugs, so this year we plan to focus our efforts on the stable supply of national essential medicines. As in the case of last year’s case where the center urgently imported from Australia to solve the domestic shortage of antipyretics and analgesics due to COVID-19, domestic We will develop our capacity so that the center can play a big role in the stable supply of medicines.” ▶ Please explain the promotion project in a little more detail. “As revealed in the name of the center, the primary goal is to supply medicines that have lost their market function, such as orphan drugs and national essential medicines, from state institutions. Whether it is an orphan drug, an essential drug, or a drug with usage monitoring, a situation in which supply and demand arise means that the function of the market appears in an abnormal situation. It depends on whether or not, but for orphan drugs, at least a network is built with data on suppliers and countries. This year, it plans to build an information network for essential medicines and medicines that require on-site supply and demand monitoring. The Ministry of Food and Drug Safety signed a contract for a consignment project to build an information network last week. Internally, a program is being developed to increase the accuracy of usage statistics for essential medicines. We will complete it within this year so that production and usage can be predicted based on statistical data. " ▶ Recently, there have been cases of drug price adjustments due to shortages, and we know that orphan essential drugs have the biggest concern about profitability. Are there separate studies in this regard? “Because the center is a non-profit corporation under the Ministry of Food and Drug Safety and does not operate a profit-making business, there is no need to adjust the price of medicines supplied by the center due to a shortage of medicines. There was a case that this center that had an impact on the drug price. Last year, the drug price of 'Natasin Eye Suspension' was adjusted due to the increase in the unit price of medicine." ▶Please explain the on-site drug supply and demand monitoring project. “The center is operating an on-site supply and demand monitoring center with 7 professional organizations, including the Korea Hospital Pharmacists Association, the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Biopharmaceutical Association, the Global Pharmaceutical Industry Association, the Korea Biopharmaceutical Association, and the Korea Pharmaceutical Distribution Association. Each organization When a request for medicines in need of supply is made through expert consultation, supply-related issues are informed and solutions are sought.” ▶The budget for the center increased from 3.3 billion won last year to 4.6 billion won this year. How will the increased budget be used? “The main items of the center’s increased budget this year are 490 million won for consignment manufacturing and 600 million won for office relocation, and isoproterenol hydrochloride injection will be introduced as a new consignment manufacturing item to address the need for a stable supply of medicines that have been continuously raised.” We plan to move the center to the Post Tower adjacent to Myeongdong Station in June. The building located along the main road will make it more convenient for users of the center." ▶At the plenary meeting of the Health and Welfare Committee of the National Assembly held on the 9th, it was pointed out that it is necessary to secure personnel exclusively responsible for monitoring the supply and demand situation of medicines in the Korea Rare Essential Drug Center and to establish a close cooperation system with medical and pharmaceutical organizations. "This year, we plan to strengthen the monitoring of discontinued medicines through the administrative network linked to the Ministry of Food and Drug Safety by further activating the operation of the on-site drug supply and demand monitoring network. In particular, actively promote two-way communication between supply and demand monitoring networks through real-time information sharing with 7 specialized organizations Through this, we intend to strengthen the monitoring of unstable supply together.”
- Company
- Keytruda leads the market for 3 consecutive years
- by Chon, Seung-Hyun Feb 22, 2023 05:54am
- The immuno-oncology drug Keytruda has topped the rank in pharmaceutical sales for 3 consecutive years. Also, new drugs from multinational pharmaceutical companies, such as Gardasil 9, Prolia, Opdivo, and Dupixent showed strong growth and joined the KRW 100 billion club after exceeding KRW 100 billion in sales last year. On the 22nd, according to the pharmaceutical research institution IQVIA, MDSD's Keytruda's sales topped the market by recordeingKRW 239.6 billion last year. This is a 19.7% YoY increase from the previous year. This is the third consecutive year the drug has held the lead after taking the top spot for the first time in 2020 with sales of KRW 155.7 billion. Also, Keytruda’s sales exceeded 200 billion won for 2 consecutive years since 2021. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head, and neck cancer, ▲ Hodgkin lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion. However, its sales started to surge with reimbursement approval. After reimbursement was applied for non-small-cell lung cancer (NSCLC) in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018, and then exceeded KRW 100 billion by 2019. In 2020, the drug outsold the then-lead Lipitor and rose to the lead. Last year, Keytruda continued strong growth amid favorable and unfavorable events. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement extension to first-line treatment of NSCLC in March this year. Its sales in Q1 last year had fallen 8.4% compared to the same quarter the previous year due to the price cut – to KRW 40.4 billion – but it recovered its momentum after the benefits from its first line reimbursement were applied in earnest. When considering the price cut that was applied to Keytruda, its sales volume has increased by over 60%. New drugs from multinational pharmaceutical companies showed strong sales and made the ranks last year. MSD’s HPV vaccine Gardasil 9 ranked third last year with sales of KRW 117 billion, rising 61.2% from the previous year. Gardasil 9 is an improved version of the company’s Gardasil, which offers protection for four serotypes (6, 11, 16, and 18). Gardasil 9 offers protection for five more serotypes (31, 33, 45, 52, 58) than Gardasil. Also, It contains the most HPV types among cervical cancer vaccines. Vaccinations among males for Gardasil 9, which was released at the end of 2016, have also been rising every year with the news spreading that Gardasil 9 offers protection for HPV-related diseases other than cervical cancer, such as anal cancer, genital warts, and precancerous lesions. Also, the revaccination rate has also risen greatly among adults who already received vaccination after the recommended age was expanded from 9-26 to 27-45 in July 2020. Sales of Gardasil 9 had increased over twofold in 2 years from KRW 42.5 billion in 2020 to exceed KRW 100 billion for the first time last year. Amgen’s Prolia ranked fourth raising KRW 115.7 billion YoY last year. Prolia, a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone, was released in November 2016 in Korea. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively and its annual sales exceeded KRW 100 billion for the first time. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 29.3% YoY to record ₩109.9 billion this year. Opdivo, which was approved in 2015, recorded a high growth rate of 64.7% in two years from the 66.7 billion it had earned in 2020, and its annual sales exceeded 100 billion for the first time last year. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.3% YoY to record ₩105.2 billion last year. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020, and exceeded KRW 100 billion last year. Roche’s Perjeta’s annual sales rose 9.4% YoY to record KRW 102.7 billion last year. Perjeta is approved for use in combination with docetaxel and trastuzumab in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. The drug was approved for reimbursement to treat patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy in 2017. After the drug was granted selective reimbursement in May 2019, trastuzumab and combination therapy settled as the standard adjuvant therapy and its sales exceeded KRW 100 billion. Among new drugs developed by domestic pharmaceutical companies, HK.Inno.N’s K-CAB’s sales rose 16.0% YoY to record KRW 104.8 billion and ranked eighth last year. K-CAB, which was released in March 2019. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion.
- Company
- GC Biopharma receives WHO Pre-Qualification for Barycela
- by Kim, Jin-Gu Feb 21, 2023 05:52am
- Pic. of Barycela GC Biopharma announced that the World Health Organization (WHO) has granted prequalification (PQ) for its varicella vaccine, Barycela. Vaccines that receive the WHO prequalification decision after a review of their safety and efficacy become eligible for procurement by the United Nations agencies to be used in national immunization programs. With the approval of its varicella vaccine, the company now owns 3 PQ vaccines along with its H1N1 pandemic and seasonal influenza vaccines. Barycela is a live attenuated varicella virus vaccine that contains the MAV/06 strain, a virus exclusively attenuated by GC Biopharma. The product has improved stability while containing a higher amount of virus compared to its previous product. In a global trial, the company demonstrated Barycela’s noninferiority in terms of immunogenicity and an equivalent level of safety compared with Varivax, an existing prequalified vaccine in the market. The vaccine is produced in a state-of-the-art aseptic system through cell culture, virus infection, and purification. It has the characteristic of being the only varicella vaccine produced without antibiotics. With the WHO's PQ decision, the company believes that there is a rising possibility that its ‘MAV/06 strain’ will be registered in the WHO Technical Report Series (TRS) in addition to the previously listed OKA strain. Also, GC Biopharma plans to actively target the global market with Barycela by utilizing the global supply network it had previously established supplying its existing varicella vaccine. Eun Chul Huh, President of GC Biopharma, said, “We hope to continue contributing to reducing the world's social and economic cost incurred by varicella outbreaks with Barycela.” In 1993, GC Biopharma received approval for ‘Suduvax,’ the first varicella vaccine in Korea and the world's second varicella vaccine. Over 28 million doses of Suduvax have been sold worldwide over the past 3 decades through PAHO and others.
- Company
- 3rd PARPi Talzenna may be prescribed at hospitals in Korea
- by Eo, Yun-Ho Feb 21, 2023 05:52am
- Korea’s third PARP inhibitor, ‘Talzenna’ can now be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) treatment ‘Talzenna (talazoparib)' passed the drug committee reviews of various medical institutions in Korea, including the National Cancer Center St. Mary’s Hospital and Yeouido St. Mary's Hospital. Talzenna was approved in Korea in July 2020 as monotherapy for the treatment of adult patients with germline BRCA mutations who have HER2-negative locally advanced or metastatic breast cancer with previous treatment experience. Afterward, the company applied for reimbursement, and the agenda was selected for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in November of the same year but was unable to pass CDDC deliberations, and no progress had been made since. The health authorities are known to have been expressing concerns about reimbursing PARP inhibitors like Talzenna in breast cancer due to their broad indication in the disease. AstraZeneca’s Lynparza was the first PARP inhibitor to receive reimbursement in Korea. Lynparza was listed for reimbursement in October 2017 and was applied the Expenditure Cap type of the Risk Sharing Agreement (RSA) through the pharmacoeconomic evaluation exemption system. Listing of Takeda’s ‘Zejula’ followed in December 2019. The drug may be prescribed as maintenance monotherapy for adult patients with platinum-sensitive recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy. However, its first reimbursement was only approved for approved the BRCA-positive indication. However, both drugs are experiencing difficulty extending reimbursement to breast cancer. Meanwhile, Talzenna’s efficacy was demonstrated through the large-scale, open-label, randomized, international Phase III trial, EMBRACA. The trial compared the efficacy of Talzenna monotherapy versus chemotherapy of the investigator’s choice in patients with gBRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. Results showed that the median progression-free survival (mPFS), the primary efficacy endpoint, was 8.6 months for the Talzenna monotherapy arm, which was a significant improvement compared with the 5.6 months in the chemotherapy arm. Also, the risk of disease progression or death was 46% lower in the Talzenna monotherapy arm compared to the chemotherapy arm. Such significant improvement in PFS in patients treated with Talzenna was consistently observed across major patient subgroups, which were defined by the number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases. Also, the secondary endpoint, objective response rate (ORR), was 62.6% for the Talzenna monotherapy arm, which was more than double the 27.2% achieved in the chemotherapy arm.
- Policy
- Severe Cancer Drug Benefits, covered by the National Budget
- by Lee, Jeong-Hwan Feb 20, 2023 05:53am
- The legislation will be promoted in which the state is responsible for the cost of applying health insurance benefits for new drugs for the treatment of severe diseases and cancer. It also included a provision to include a new technology support project for cancer treatment in the scope of the National Health Insurance Service's work and to raise the funding rate used for new technologies for cancer treatment. On the 14th, Kang Sun-woo, a member of the Democratic Party of Korea, announced that he proposed three amendments to the Cancer Management Act, the National Health Insurance Act, and the National Health Promotion Act. Lawmaker Kang plans to name the three package bills proposed this time as the "Three Acts of State Responsibility for Severe Diseases" and push for legislation. The current law stipulates that cancer treatment and medical expenses should be subsidized according to income level to ease the economic burden of severely ill patients and cancer patients. However, it has been pointed out that in the current medical expenses support system, the limit of support is limited. Cancer patients are in financial difficulties and lose their lives due to the lack of rapid health insurance benefits after the approval of the Ministry of Food and Drug Safety. In response, Kang proposed a new support project to support new non-paid cancer treatment and new medical technology from the budget of the National Health Promotion Fund and included new cancer treatment technology support projects within the scope of the National Health Insurance Corporation's work. It also specified legal grounds for raising the National Health Insurance Service fund support rate (partial amendment to the National Health Promotion Act) used for related support projects such as new cancer treatment technologies. Lawmaker Kang said, "We proposed the bill in the sense that strengthening the coverage of drugs for severe diseases directly related to the lives of the people should be carried out more actively with government support."
- Policy
- The Minister's willingness to innovate regulations
- by Lee, Hye-Kyung Feb 20, 2023 05:53am
- A full view of Hanmi Pharmaceutical Oh Yoo-kyung, head of the Ministry of Food and Drug Safety, met with representatives of pharmaceutical companies and expressed his willingness to innovate regulations. At 2 p.m. today (15th), Director Oh met with representatives of pharmaceutical industries such as Hanmi Pharmaceutical, Dasan Pharmaceutical, Daewoong Pharmaceutical, Amgen Korea, Inist, Pfizer Korea, Huons, and Hugel at the Hanmi Pharmaceutical Research Center. The meeting was held in the name of the New Year's meeting, and the reason why Hanmi Pharmaceutical Research Center was selected as a venue is to encourage executives and employees of Hanmi Pharmaceutical, which has been approved for marketing by the U.S. FDA, for the first time in Korea. In September last year, Hanmi Pharmaceutical received FDA approval for the treatment of neutropenia, "Rolontis." "We are grateful for the hard work of the company officials who are striving to develop the domestic pharmaceutical industry and improve their international status," Oh said. "The Ministry of Food and Drug Safety will also do its best to improve the drug system and provide administrative support." It announced its plan to boldly change Korean drug regulations to global standards so that domestic companies can enter and compete in overseas markets. "The Ministry of Food and Drug Safety will work closely with the industry and related organizations to promote regulatory innovation so that Korean drug regulations can lead the international standards," Oh said. "Please continue to develop high-quality new drugs to open new treatment opportunities for our people." The meeting was held to introduce major policy directions and core brand businesses of the Ministry of Food and Drug Safety in 2023 and to discuss future development and regulatory innovation measures of the Ministry of Food and Drug Safety with related industry officials. The Global Leader, Partner, Supporter (GPS) project was introduced as a major policy in the pharmaceutical sector, which means accelerating entry into the international market through global leadership to strengthen export support, partners in pharmaceutical production using advanced digital technology, and customized support for global innovative products. The Ministry of Food and Drug Safety plans to support the virtuous cycle of the pharmaceutical industry by enhancing Korea's international status and becoming a leading regulatory country through international harmonization of pharmaceutical regulations. Previously, it operated a Global Innovative Products on Fast Track (GIFT) program to help global innovative medical products become quickly commercialized and dominate the global market. It said it would implement customized regulatory support projects to quickly enter the next-generation biopharmaceutical market. The plan is to establish a preemptive item classification system for new concept drugs as the development of new concept products that transcends the classification and concept of existing drugs is expanded. If a biopharmaceutical company applies for and discovers next-generation biopharmaceuticals, it will support regulations through internal communication, classification standards, customized regulatory support, internal review committee, external consultation, notification and objection, procedures, and information provision. To secure vaccine sovereignty, it also announced plans to operate a national cell bank, test and analysis of vaccines at an international level, comprehensive technology consulting from vaccine development to licensing, overseas licensing strategy consulting, and expand the foundation for future-oriented policy and system development. The Ministry of Food and Drug Safety said it will continue to play the role of a regulatory agency that protects public safety based on regulatory science expertise, push for export GPS strategies to enter the global market beyond global technical regulations, and play a role as a partner in organically communicating and cooperating with industries and organizations.
- Company
- Organon ‘Samsung’s Humira biosimilar to make KRW 100 billi
- by Jung, Sae-Im Feb 20, 2023 05:53am
- Samsung Bioepeis’ U.S partner Organon projected that the sales of the company’s Humira biosimilar will reach a maximum of KRW 123.5 billion in the first year of its release. On the 16th (local time), Organon projected so while presenting its full-year 2022 financial results, announcing that the company “will be launching the Humira biosimilar ‘Hadlima’ in the U.S. July this year.” Hadlima is a Humira biosimilar that was developed by Samsung Bioepis. Humira is a blockbuster drug that held the ranks as the most-sold drug worldwide for a decade. Its global sales recorded USD 21.24 billion (approximately KRW 27 trillion) last year, of which sales in the U.S. accounted for USD 18.62 billion (approximately KRW 24 trillion). Starting with Amgen, various companies including Samsung Bioepis, Boehringer Ingelheim, Pfizer, and Coherus are set to release Humira biosimilars this year. Amgen’s ‘Amjevita’ has already been released to the market. In particular, up to 8 companies including Samsung Bioepis are expected to competitively release their biosimilar products in July this year. Building on their successful launch of Hadlima in Canada and Australia, the company expects the experience to positively impact the launch in the U.S. market. Also, it pointed to Hadlima’s equal product composition and pen device technology as what differentiates its biosimilar from other products. Organon said, “We have launched Hadlima in Canada and Australia in 2021 and achieved good results. The data we collected from the launches will support our launch of the same in the U.S. Both the citrate-free, high-concentration formulation and the low-concentration formulation will be released then. The design of the pen that contains the drug can also be a differentiating factor. As a device design and manufacturing expert, the company designed the pen to ensure a smooth transition for the patients switching from Humira to Hadlima.” Organon expects Hadlima to make sales of up to USD 96.75 million (KRW 123.5 billion) this year, the first year of its launch in the US. This amount was derived based on the expectation that Hadlima sales will not exceed 1.5% of the estimated total sales of USD 92.25-96.75 million (KRW 117.8-123.5 billion), which roughly amounts to USD 92.25-96.75 million (KRW 117.8-123.5 billion). This will be around fivefold of what Hadlima made last year (USD 19 million, KRW 24.2 billion). Organon said, “We expect sales of Hadlima to rise gradually with competition among biosimilars to be officially listed by major Pharmacy Benefit Managers (PBMs) in the U.S. From the next year after the biosimilar market is formed in earnest, Hadlima will grow into Organon's second largest grossing product.” The ‘interchangeable biosimilar’ designation sought by Samsung Bioepis was expected to be achieved in Q2 to Q3 of 2024. The interchangeable biosimilar designation is made by the U.S. Food and Drug Administration for biosimilars that are very similar to and have no clinically meaningful differences from the original drug. Drugs that are approved as interchangeable biosimilars may be substituted at the pharmacy without a separate order for switching by the prescribing health care provider. Organon said, “We expect to be able to receive the interchangeable biosimilar designation around one year after Hadlima’s release in July. Our other Humira biosimilar competitors will also be able to receive designation by then. For the first 1-2 years after a drug is launched, whether the drug received the interchangeable biosimilar designation does not become a key point of differentiation for biosimilars during discussions with PBMs. As long as give convince them that we can receive the designation within a reasonable period of time, it will not be a major point for discussion at the negotiation table."
