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- Company
- Bispecific multiple myeloma drug 'Talvey' can be prescribed
- by Eo, Yun-Ho Mar 21, 2025 06:00am
- New bispecific multiple myeloma drug 'Talvey' can now be prescribed at general hospitals. According to industry sources, Janssen Korea's Talvey (talquetamab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National Univeristy Hospital, and medical institutes, including Pusan National University Hospital and Chung-Ang University Hospital. Talvey was approved by the Ministry of Food and Drug Safety (MFDS) as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received over three prior lines of treatments, including proteasome inhibitors, immune modulators, and anti-CD38 monoclonal antibody. Multiple myeloma is a type of cancer with the number of patients increased by over 60% in the past 10 years. Many patients with multiple myeloma experience relapse. According to a cohort study, multiple myeloma patients who had received more than three types of treatments, including anti-CD38 monoclonal antibody, demonstrated an overall response rate (ORR) of below 30%, with short life expectancy and poor prognosis. Consequently, patients needed a treatment option with a new mechanism. Talvey is a first-in-class bi-specific antibody drug approved in South Korea, targeting CD3 receptor and G protein-coupled receptor class C group 5 member D (GPRC5D). It can be administered to patients who had previously used proteasome inhibitors, immune modulators, or anti-CD38 monoclonal antibodies. The efficacy of Talvey was demonstrated through the global clinical trial, 'MonumenTAL-1 study.' The study results showed that 143 patients who do not have prior treatment experience with T-cell redirecting therapy were treated with Talvey 0.4 mg/kg every week. The patients treated with Tarvey had an ORR of 74.1% and a stringent complete response (sCR) of 24%. Patients demonstrated 10% complete response (CR) and 26% very good partial response (VGPR). Meanwhile, bispecific antibody drugs are immune cell therapy consisting of two monoclonal antibodies that recognize targeted antigens and T cells of multiple myeloma. For instance, bispecific IgG2 kappa antibody, consisting of two monoclonal antibodies that recognize B-cell maturation antigen (BCMA) and CD3 antigens, is commonly used. It is a new therapy that directly delivers cytotoxicity-triggering T-cells into multiple myeloma cells expressing BCMA. Bispecific antibodies approved in South Korea include Pfizer's 'Elrexfio (elranatamab)' and Janssen's 'Tecvayli (teclistamab),' and Talvey. These drugs remain as non-reimbursed drugs.
- Company
- Prevnar 20 added to the National Immunization Program
- by Whang, byung-woo Mar 21, 2025 05:59am
- Pfizer is signaling full-fledged competition with the addition of its new pneumococcal vaccine, Prevnar 20, to the National Immunization Program (NIP) for children. According to industry sources on the 21st, the Korea Disease Control and Prevention Agency recently reviewed the introduction of PCV20 NIP for children during the 1st Korea Expert Committee on Immunization Practices meeting. As a result, the committee decided that PCV20 would be introduced under the NIP, for the same target population and standard immunization schedule as for PCV13 and PCV15, which were already covered through the NIP. Initially, it was widely believed that the entry of Prevnar 20 into the NIP would be delayed to next year because the Public Procurement Service announced a plan to execute a tender for the purchase of Prevnar 13, but discussions progressed with Pfizer compromising its price with the government. At the meeting, the committee allowed the cross-vaccination of Prevnar 20 as an exception for the additional immunization after completing basic immunization with Prevnar 13. Currently, the vaccine price and immunization practice for pneumococcal vaccines are fully covered by the government for children under the age of 12. Both Prevnar 13 and Prevnar 20 are administered once to adults aged 18 or older, but infants and those who have not received the basic vaccination are required to receive multiple doses at regular intervals depending on the number of months. For example, Prevnar 13 is administered 3 times at 0.5 mL per dose at 2, 4, and 6 months of age in infants up to 6 months of age, so those who started this vaccination with Prevnar 13 may receive subsequent vaccination with Prevnar 20. In fact, Prevnar 20 is indicated for “Infants, children, and adolescents who have received at least 1 dose of Prevnar/Prevnar 13 may switch to Prevnar 20.” Prevnar 20 is a new pneumococcal vaccine that Pfizer has introduced in 14 years, and it is a vaccine that adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously supplied Prevenar13. The industry believes that although Prevnar 13 is already on the market, the weight will naturally shift to using Prevnar 20. Pfizer is expected to accelerate preparations for the launch as the pediatric NIP, which had been a concern for the launch, has been resolved. The industry expects the launch of Prevnar 20 to take place in April, and the sales of Prevnar 20 for infants and toddlers will be maintained by Korea Vaccine, which was previously in charge of sales of Prevnar 13. The company is likely to employ a sales strategy that naturally absorbs the market share of its predecessor, Prevnar 13. In the case of Vaxneuvance, the company’s strategy is important as its competitor entered the market just one year after its launch. It is predicted its company will seek opportunities in the timing when people switch from Prevenar 13 to another vaccine. During the media seminar that was held last year for Vaxneuvance, Jaeyoung Cho, Executive Business Unit Director of Vaccines at MSD, said, “The number of infants and toddlers receiving their initial dose of the pneumococcal vaccine, which is covered through NIP, as well as those switching from the existing 13-valent vaccine to Vaxneuvance have been increasing.” “Like Vaxneuvance, which was also applied to the NIP upon its release, we expect Prevnar 20 to quickly expand its influence in the market,” said a vaccine industry official. ”Since both Prevnar 13 and 20 are Pfizer vaccines, the switching hurdle is relatively low, so MSD would likely be considering countermeasures.”
- Policy
- Enhertu’s reimb may be extended to gastric cancer
- by Lee, Tak-Sun Mar 21, 2025 05:59am
- The number of patients who can use the new antibody-drug conjugate (ADC) anticancer drug ‘Enhertu Inj (trastuzumab deruxtecan, Daiichi Sankyo Korea), which has been reimbursed since April last year, is expected to be expanded to cover eligible gastric cancer patients. This is an expansion in the scope of existing patients eligible for reimbursement. The Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee voted on the 19th to expand the reimbursement coverage of Enhertu. Enhertu is a next-generation ADC that combines a monoclonal antibody with the same structure as trastuzumab, which binds to a specific target receptor overexpressed on the surface of cancer cells, and a topoisomerase I inhibitor payload with a tumor-selective cleavable linker, which is a novel and highly potent mechanism of action. The drug is expected to have a higher therapeutic effect than existing anticancer drugs. The drug was added for reimbursement in April last year by applying a flexible incremental cost-effectiveness ratio (ICER) threshold, an indicator of economic efficiency. As a result, the patient's burden from annual medication costs was reduced from KRW 80 million to KRW 4 million. At the time, the reimbursement standard for gastric cancer patients was set as locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction that satisfies all three conditions. The conditions were: patients who ①failed two or more prior therapies, including trastuzumab (Herceptin) +(fluorouracil or capecitabine)+cisplatin; ②have HER2 overexpression (IHC 3+ or 'IHC 2+ and FISH+ or SISH+’) metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; and ③have an ECOG performance status (PS) of 0 or 1. This expansion of the reimbursement standard this time will extend the scope of the drugs limited to cisplatin in the first condition to other platinum-based anticancer drugs. As a result, it is expected that not only cisplatin but also patients with gastric cancer who have failed to receive oxaliplatin (original Eloxatin) will be able to receive Enhertu with reimbursement. “Enhertu’s reimbursement expansion agenda extends the conditions limited to cisplatin among platinum-based anticancer drugs in the existing reimbursement standards to other platinum-based anticancer drugs,” said a HIRA official. “This is expected to further expand patient access.” The applications for which the reimbursement standards have been established at this meeting will be reviewed by the Drug Reimbursement Evaluation Committee to determine their reimbursement adequacy.
- Opinion
- [Reporter’s View] New Drug Trends and Choline Alfoscerate
- by Lee, Tak-Sun Mar 21, 2025 05:57am
- The Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, which holds meetings every month, is the biggest hurdle to reimbursement in Korea and helps identify the latest new drug trends. For several years now, the keywords that have led the trend were “anticancer drugs,” “rare drugs,” “biological drugs,” and “high-priced drugs.” Contrary to how the trend leaned toward chronic disease treatments that owned a large patient population in the past, biologic targeted treatments for a small number of patients have become the trend these days. The characteristic of these drugs is that they are expensive. In line with the trend, the Health Insurance Review and Assessment Service and the National Health Insurance Service are in the process of establishing a system to manage such high-priced anticancer and rare drugs. Global pharmaceutical companies are now investing in anticancer and rare drugs with fewer patients and less competition, rather than developing synthetic drugs for chronic diseases, which become flooded with generics upon patent expiry. The companies’ investments have now been making results at the Drug Reimbursement Evaluation Committee level. However, the names of domestic pharmaceutical companies are rarely mentioned at DREC due to their lack of new drug development. Occasionally, the release of a new homegrown drug arises as a hot topic, but usually, the main players deliberated by DREC are multinational pharmaceutical companies. Domestic pharmaceutical companies are increasingly drifting apart from the new drug trend. Traditional pharmaceutical companies have missed the timing when biosimilar development began in the mid-to-late 2000s. When a bio-venture called Celltrion announced its challenge into the biosimilar field, the other companies ignored it, saying things like “there is no real profit” and “there is little chance of success.” When Samsung followed into the biosimilar market and achieved economies of scale, it was already too late. Currently, the top 2 pharmaceutical and bio companies in Korea are Celltrion and Samsung Biologics. I wonder what would have happened if domestic pharmaceutical companies had invested in biosimilars with the capital they had at the time, with a view to the future. Biosimilars are just one trend. The pharmaceutical market has been changing rapidly for the past decade. New diabetes drugs have been introduced one after another, and the cancer drug market has evolved from treatments targeting resistant mutations to immuno-oncology drugs such as Keytruda. The pace of pharmaceutical trends is too fast for Korean pharmaceutical companies to keep up with them, with the big pharma companies aggressively buying rare disease treatments through mergers and acquisitions. Nevertheless, Korean pharmaceutical companies are still stuck in the past. Many of the top-selling products of Korean pharmaceutical companies are the brain function enhancer, choline alfoscerate, which is already nearly 30 years old. In 2020, the government’s re-evaluation reduced the indications for the drug, and even though clinical trials are still underway due to doubts about their efficacy, sales of choline alfoscerate drugs have grown. It is a reliable cash cow for pharmaceutical companies. On the 13th, the Supreme Court ruled in favor of the government in a lawsuit filed by 26 pharmaceutical companies to cancel the notice of selective reimbursement of choline alfoscerate. With this ruling, it is likely that their selective reimbursement, which has been deferred with the lawsuit, will soon become a reality. If reimbursement for the drug is only applied to dementia diseases and excludes mild cognitive impairment, choline alfoscerate will no longer be able to serve as a cash cow for domestic pharmaceutical companies. While domestic pharmaceutical companies have managed to maintain their sales by defending the reimbursement reduction for their choline alfoscerate products for 5 years, this may have rather pushed companies to fall further behind in the market trends of anticancer drugs and orphan drugs. Of course, there are also pharmaceutical companies, such as Boryung and Handok that are increasing investment in the anticancer and orphan drug markets. However, there is concern whether most pharmaceutical companies will lose their investment timing as they struggle to maintain domestic sales, as was the case during the biosimilar boom. The global market's number one immuno-oncology drug, Keytruda’s follow-on is a biosimilar, not a generic drug. Celltrion and Samsung Biologics have just begun development efforts, but it is just a hope for domestic pharmaceutical companies.
- Company
- Hanmi and Samsung Bioepis join forces to sell Prolia similar
- by Cha, Jihyun Mar 20, 2025 06:01am
- Hanmi Pharmaceutical and Samsung Bioepis announced on the 19th that they had signed a joint sales agreement on the 18th for the domestic launch of the osteoporosis treatment Prolia biosimilar (Project name: SB16, ingredient name: denosumab) in Korea. Under the agreement, Samsung Bioepis is responsible for the production and supply of the product as the developer of the Prolia biosimilar. Afterward, both companies will jointly be in charge of domestic marketing and sales activities. Prolia is an osteoporosis treatment developed by Amgen. As of 2024, its global sales neared approximately KRW 6.5 trillion. According to IQVIA, the size of its domestic market sales in 2024 is expected to be approximately KRW 174.9 billion. Currently, Samsung Bioepis is in the process of obtaining approval for the Prolia biosimilar in Korea. It was approved in the US and Europe, by the respective regulatory authorities in February. Hanmi Pharmaceutical and Samsung Bioepis plan to establish a close cooperative relationship and strive to provide patients with the opportunity to use biopharmaceuticals at more reasonable prices. “Based on our development capabilities and Hanmi Pharmaceutical's sales and marketing expertise, we will work closely together to ensure that Korean patients can experience more benefits from the prescription of our biosimilar,” said Kyung-ah Kim, CEO of Samsung Bioepis. “Hanmi Pharmaceutical is a ready partner that has already established a foothold in the musculoskeletal treatment market,” said Jae-hyun Park, CEO of Hanmi Pharmaceutical. ”Through this partnership, we aim to create innovative results that will enable mutual growth for both companies and will continue to work closely together.”
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