- LOGIN
- MemberShip
- 2025-12-27 15:27:24
- Company
- Biosimilar Ultomiris to follow Soliris next year at earliest
- by Kim, Jin-Gu Nov 04, 2019 03:12pm
- Sources predict Ultomiris would enter the Korean market and a competition against a blockbuster antibody, Soliris, next year. According to pharmaceutical industry on Oct. 30, the drug manufacturer of Ultomiris, Alexion is preparing for a launch in Korea at the end of next year. The follow-on antibody drug already has been approved by FDA in the U.S. and by EMA in Europe last December and July, respectively. Like the case with Soliris, Handok is highly likely to manage Ultomiris’ approval and healthcare reimbursement application in Korea, but sales and marketing company has not been decided, yet. Currently, Handok is in charge of Soliris’ sales and marketing in Korea. Both Alexion and Handok are hesitant to give a clear plan, as they are still working on Ultomiris’ approval in Korea first. An official from Handok said, “Handok would be handling Ultomiris’ application for approval and healthcare reimbursement listing. At this point, it is still too early in the process for both companies to discuss about approval application schedule in Korea” and “sales and marketing contract would be dealt with after they are handled”. Alexion insider hinted, “Specific schedule has not been set, yet, but we are aiming to get approval from Korea at the end of next year”. Now the title has been taken away, but Soliris used be called the ‘most expensive drug in the world’. In 2010, it costed 500 million won for a year-long treatment of Soliris. Worldwide sales marked USD 3.14 billion (about 3.59 trillion won). The patient size may be small but because of its extremely expensive price, the sales volume is still massive. However, Soliris is soon to face biosimilar competitors as its patent expiration date is approaching. In the U.S., Amgen has reportedly filed a suit invalidating patent for Soliris as a preparation for an early release of its biosimilars product. If Amgen wins the case, the original patent expiration in 2027 would be moved up as early as 2021. In Korea, Samsung Bioepis and Abxis are currently developing biosimilars. Prospective competitors expect their products to excel in the market considering the original cost 500 million won a year. Alexion’s Ultomiris launch prep is also closely related to the original patent case. The blockbuster original and the biosimilars have overlapping indication of ▲paroxymal nocturnal hemoglobinuria (PNH) and ▲atypical hemolytic uremic syndrome (aHUS). Also the market could favor Ultomiris over Soliris as number of annual injection is about a quarter of Soliris’. The original is supposed to be shot once every other week, whereas Ultomiris is shot once every eight weeks. Summing up a year worth of injections, Soliris and Ultomiris are shot 26 times and six to seven time a year (52 weeks), respectively. Accordingly, the drug expense for Ultomiris would be significantly lower. A global pharmaceutical industry analytic firm, EvaluatePharma has once evaluated Ultomiris’ market value at 10.9 billion dollars (about 12.26 trillion won). The figure is over a triple of Soliris’ global sales volume of 3.14 billion dollars.
- Company
- Korean Pharma wins first-instance ruling in patent challenge over Sirturo
- by Kim, Jin-Gu
- Generic drugmakers have secured a first-instance victory in a patent dispute surrounding Sirturo (bedaquiline), a treatment for tuberculosis.According to industry sources on the 19th, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of BC World Pharmaceutical and Yungjin Pharm in a passive scope confirmation (non-infringement) trial concerning the composition patent for Sirturo Tab (Patent No. 10-1514700), filed against Janssen. The two companies had submitted the petition in September.With the favorable ruling in the avoidance trial, analysts say BCWorld and Yungjin have moved one step closer to early market entry for generic versions of Sirturo.Three Sirturo Tab patents are listed in the Ministry of Food and Drug Safety's patent directory. The substance patent expired this June. Excluding this, a use patent expiring in December 2026 and a composition patent expiring in December 2027 remain.BC World and Yungjin’s strategy is to avoid the composition patent expiring in 2027 and strategically launch generics early, promptly upon the expiration of the use patent next year.Sirturo is Janssen’s tuberculosis treatment that was approved in 2014. It features a novel mechanism of action that inhibits the energy metabolism of Mycobacterium tuberculosis and is used in the treatment of multidrug-resistant tuberculosis (MDR-TB). The World Health Organization (WHO) recommends Sirturo as one of the standard treatments for MDR-TB.According to the MFDS, Sirturo recorded import sales of USD 4.1 million (approximately KRW 5.7 billion) in 2023. Although the overall market size is relatively small, the drug has become a key target for generic manufacturers due to the lack of suitable alternatives in MDR-TB treatment. Furthermore, given that tuberculosis treatment regimens last nearly a year, the launch of a generic version is expected to enable stable revenue generation.
