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- 2026-05-06 11:07:03
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- US approval of Celltrion Yuflyma was delayed
- by Feb 24, 2023 05:53am
- Celltrion has confirmed that the U.S. Food and Drug Administration (FDA) will complete the Yuflyma final approval review by May of this year. Celltrion announced on the 23rd that it had confirmed that the final approval review of Yuflyma would be completed by May of this year while continuing discussions with the FDA. Earlier, the U.S. approval process for Yuflyma was somewhat delayed as foreign finished drug manufacturers in charge of finished product production received criticism from the FDA. Celltrion emphasized that the delay in FDA approval of Yuflyma was due to the situation of overseas finished manufacturing plants that had nothing to do with Celltrion's own technology. Overseas finished drug manufacturing plants received an appropriate grade by resolving the issues pointed out after FDA inspections. The conformity level is a level given when a manufacturer voluntarily requests corrective action when unreasonable matters are found but the violation is not serious. Celltrion Group will be able to sell Uplyma in the US from July 1 after reaching a patent agreement with a company that owns Yuflyma's original drug. Apart from FDA approval, we are working on a pre-work to introduce the product to the US market in time for the launch. Celltrion Healthcare acquired Celltrion USA in August last year for direct sales in the United States, securing a license and distribution network for pharmaceuticals in the United States. It has completed securing local experts to lead the US business by recruiting Thomas Nusbickel, who has extensive experience in biosimilar commercialization at global pharmaceutical companies, as CCO of the US corporation.
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- Shingrix may be prescribed in 93 general hospitals in Korea
- by Eo, Yun-Ho Feb 24, 2023 05:52am
- The shingles vaccine ‘Shingrix’ has quickly landed in medical institutions in Korea after starting vaccinations. According to industry sources, GSK Korea’s recombinant vaccine Shingrix passed review by drug committees of 93 medical institutions in Korea, including tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, Asan Medical Center - as well as general hospitals - Kangbuk Samsung Medical Center, Kyung Hee University Medical Center, Korea University Hospital (Buro, Anam, Ansan), Soonchunhyang University Hospital Seoul, Ajou University Hospital, and Hanyang University Hospital. Considering how vaccination had started in December in earnest, the vaccine has settled quickly in the market. Shingrix is the first shingles vaccine approved in Korea that combined a non-live antigen with GSK's vaccine adjuvant. It offers protection from shingles in adults over 50 who are at increased risk of shingles from age-related decline in immunity. In two Phase III clinical trials (ZOE-50, ZOE-70) that were conducted on 15,411 adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group and over 90% efficacy in those aged 70 years and above. The rate of serious adverse events was similar in the Shingrix arm and the placebo arm. The interim analysis of the ZOSTER-049 (ZOE-LTFU) extension study that was conducted to follow up ZOE-50 and ZOE-70 showed that Shingrix’s shingles prevention effect continued for at least 10 years after vaccination. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or have solid cancer, blood cancer, or received solid organ transplants that have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Kyung Young Yoon, Professor of Infectious Disease at Korea University Anam Hospital, said, “Complications from shingles greatly reduce patients' quality of life. Therefore, it is important to prevent this in advance. As the first and only non-live recombinant vaccine approved in Korea that demonstrated a prevention effect and safety profile through global clinical trials, I believe Shingrix will open a new paradigm in shingles prevention in Korea.” Meanwhile, GC Biopharma and Kwangdong Pharmaceutical signed a co-promotion and distribution agreement with GSK for Shingrix in Korea and are carrying out promotional activities for the vaccine.
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- Tabreca can now be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 23, 2023 05:46am
- The first MET-targeted anticancer drug, ‘Tabrecta’ can now be prescribed at hospitals in Korea. According to industry sources, Novartis Kore’s Tabrecta (capmatinib) passed the drug committees of the Big-5s general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Sinchon Severance Hospital, and medical institutions including the National Cancer Center, Pusan National University Hospital, etc. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). No treatment option had been available in this type until now, which is why attention has been rising for new drugs in the area. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in the US in May 2020. However, the issue of reimbursement still remains an obstacle. The company applied for reimbursement in November 2021 after receiving marketing authorization in Korea. However, the agenda was unable to pass review in both Health Insurance Review and Assessment Service’s Cancer Disease Review Committee meetings in August and last month this year. Whether Novartis will apply for and succeed in listing the drug for reimbursement remains to be seen. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta with other therapies. In particular, its combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum-based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso. Professor Ji-Youn Han, Department of Hemato-oncology, National Cancer Center, said, “Patients who have MET amplification or overexpression have a very poor prognosis. In this sense, with the prompt introduction of MET inhibitors becoming ever important, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance.”
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- Neulasta's sales surpassed those of Neulapeg
- by Kim, Jin-Gu Feb 23, 2023 05:46am
- Neulasta and NeulapegNeulasta and Neulapeg are competing for the lead in the neutropenia treatment market. In the fourth quarter of 2021, Neulapeg took the lead by surpassing the original product, Neulasta, for the first time after its release, but from the first quarter of last year, Neulasta took the lead again, widening the gap with Neulapeg. In the pharmaceutical industry, there is an analysis that the change is due to the replacement of sales partners. Boryung led rapid growth by co-selling Neulapeg with GC Pharma until 2021 but started co-selling Neulasta in partnership with Kyowa Kirin last year. According to IQVIA, a pharmaceutical market research institute, on the 23rd, sales of Neulasta last year were 31.4 billion won. It increased by 29% compared to 24.5 billion won in 2021. During the same period, Neulapeg showed a decrease of 6% in one year from 22.8 billion won to 21.5 billion won. Neulasta is classified as a second-generation neutropenia treatment. Neutropenia treatment is a drug that prevents the side effects of lowering immunity due to a decrease in the number of neutrophils in the body when cancer patients are administered anticancer drugs. Neulapeg is a kind of Biobetter product upgraded from Neulasta. GC Pharma applied PEGylation technology, which attaches polyethyleneglycol only to a specific location, to increase purity and stability and increase the half-life of the drug compared to existing treatments. By 2021, the neutropenia treatment market has developed in such a way that Neulapeg is chasing Neulasta. Released in 2014, Neulapeg had minimal initial commercial success. Until 2018, most quarterly sales were less than 1 billion won. However, as Boryung's sales power increased, it began to show a steep upward trend. GC Pharma signed a joint sales contract with Boryung in October 2018 for Neulapeg. Since then, it has exceeded 3 billion won in the 4th quarter of 2019, 4 billion won in the 4th quarter of 2020, and 5 billion won in the 2nd quarter of 2021, respectively. In particular, in the fourth quarter of 2021, it recorded quarterly sales of 6.3 billion won, surpassing Neulasta (5.6 billion won) and rising to the top of the market. Neulasta, new sales in one year ↑ 29% In the pharmaceutical industry, it is analyzed that the change of sales partner had a significant impact on the change in the market landscape. Boryeong, which led Neulapeg's growth until 2021, started selling Neulasta instead of Neulapeg last year. Boryeong, which contributed to Neulapeg's rise to the top at the end of 2021, led to the recapture of Neulasta, a competing product. Jeil has been co-selling GC Pharma Neulapeg since last year. Jeil had experience co-marketing Neulasta from 2014 to 2017. The gap between Neulasta and Neulapeg is widening after the change of sales partners. The gap between the two products, which was only 700 million won in the first quarter, Neulasta 6.5 billion won and Neulapeg 5.8 billion won, widened to 3.4 billion won in the fourth quarter, 8.4 billion won and 5 billion won. ◆Rolontis, a third-generation new drug, sales of KRW 1.8 billion in 2 months after the launch Rolontis is a third-generation treatment that appeared in the neutropenia treatment market after 16 years. Hanmi Pharmaceutical's Labscovery technology was applied. Compared to existing drugs, the half-life in blood was longer, so the frequency of administration was reduced to once every 3 weeks. Hanmi Pharm received domestic approval for Rolontis in March 2021. In November of last year, Rolontis was listed on the health insurance benefit list. In just two months of benefit, Rolontis posted sales of 1.8 billion won, proving its growth potential. Sales of Handokteva Lonquex and Dong-A ST Dulastin, which were second-generation products, exceeded the 4Q sales. Lonquex and Dulastin posted sales of 1 billion won and 600 million won, respectively, in the fourth quarter of last year.
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- Celltrion Eyelea expands U.S. patent
- by Feb 22, 2023 05:55am
- Celltrion researcher is conducting formulation research.(Photo by Celltrion)Celltrion is conducting an additional trial for invalidation of the U.S. patent for the eye disease treatment "Eylea." According to industries on the 17th, Celltrion recently filed an IPR (Inter Parts Review) with the U.S. Patent and Trademark Office, claiming that Eylea's composition patent developed by Regeneron is invalid. Eylea is a biopharmaceutical for treating ophthalmic diseases that treat macular degeneration and diabetic macular edema. It is a blockbuster drug that recorded $9.4 billion (about 12 trillion won) in global sales in 2021. Celltrion is developing the Eylea biosimilar 'CT-P42'. In April last year, it completed the recruitment of global phase 3 clinical patients. A total of 13 countries, including Germany and Spain, recruited patients with diabetic macular edema, which are clinical targets. Celltrion claimed that paragraph 1-18 of US patent number US 10464992 was invalid in this IPR. The patent is about polysorbate 20, sodium phosphate buffer, sucrose, etc., which are commonly used to stabilize vascular endothelial cell growth factor (VEGF) inhibitors such as Eylea. The IPR petition number is PTAB IPR2023-00462. In the petition, Celltrion stressed that the method of utilizing polysorbate 20, sodium phosphate buffer, and sucrose applied to Ailia is not novel content that can be protected by patents. Earlier in November last year, Celltrion won the first trial of an invalidation lawsuit against Regeneron for two Eylea patents (patent number US 9254338, US 9669069). This lawsuit is a lawsuit in which Celltrion jointly participated in the IPR filed by Mylan against the original company Regeneron in May 2021 through an application for participation in the lawsuit in December 2021. Celltrion also filed a lawsuit against one patent (patent number US10857231) related to Eylea formulation in September 2021. In March last year, Regeneron, the patent holder, declared the final abandonment of the patent, leading to a victory in the invalidation lawsuit. Celltrion plans to commercialize CT-P42 in time for the expiration of material patents and monopoly rights after the development of CT-P42 is completed. The patent for Eylea material is scheduled to expire in June this year in the U.S. and in May 2025 in Europe, respectively. The expiration date of the U.S. market monopoly has been extended to May 2024.
- 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.
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- 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.
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- 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.
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- 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."
- Company
- Novartis’s Jakavi makes a step towards reimb for GvHD
- by Eo, Yun-Ho Feb 20, 2023 05:52am
- ‘Jakavi’ is now one step closer to extending reimbursement to Graft versus Host Disease (GvHD) in Korea. According to industry sources, Novartis Kroea’s Jakavi (ruxolitinib) recently passed deliberation by the Drug Reimbursement Evaluation Standard Subcommittee. The next step is for the drug to be reviewed by the Drug Reimbursement Evaluation Committee. Novartis Korea submitted an application to extend reimbursement for Jakavi (ruxolitinib) to Graft-versus-Host Disease (GvHD), immediately after receiving approval for the indication in May 2022. The application passed review after being pending at this stage for 8 months. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation. When the donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damages 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-line 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 results in the field, and opened up new possibilities for patients suffering from the lack of an appropriate treatment option” 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% (96/154), compared to the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be twice higher in the Jakavi group at Day 56 at 22% (34/155) compared with 40% (61/154) in the control group.
