South Korea may not provide a prominent backdrop for noted historical developments in the pharmaceutical market, but reports that Samsung Bioepis could file a NASDAQ-listed initial public offering (IPO) within the next year are a reminder the country may emerge as an important hub in biosimilar development.
Alongside compatriot Celltrion, a precedent setting front-runner in the biosimilar monoclonal antibody market, Samsung Bioepis is implementing an externalisation strategy that combines its home-grown manufacturing capabilities with the clinical development expertise of Quintiles and the commercial presence of Merck & Co. and Biogen.
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Established in 2012 via a $300-million investment by Samsung Biologics – a joint venture between Samsung and Quintiles – and Biogen, Samsung Bioepis is rapidly becoming one of the leading Korean biosimilars players.
While Celltrion has made good progress with its biosimilar Remicade product CT-P13 – which is being commercialised across Europe and is under regulatory review in the US – it is Samsung Bioepis that is on the cusp of making rapid progress in Europe with two biosimilar approvals expected in the next 12-18 months.
With Samsung Biologics owning 85 percent of Samsung Bioepis – with Biogen owning the rest – the touted $1.3 billion IPO would mean that both companies would make a significant return on their initial investment and gain access to much needed funds to continue clinical development of its biosimilars portfolio.
Samsung Bioepis announced in January that the European Medicines Agency had accepted its biosimilar version of Enbrel (SB4) for review. The company then confirmed in March that its submission for a biosimilar version of Remicade (SB2) had also been accepted by the EMA. The company has also recently presented positive Phase I and Phase III data for both products at the recent annual meeting of the European League Against Rheumatism (EULAR).
According to FirstWord's Biosimilar Index (for more details click here), Samsung Bioepis has one of the most advanced biosimilar pipelines in the industry. In addition to having biosimilar Enbrel and Remicade under review at the EMA, the company is also developing biosimilar versions of Humira, Trastuzumab and Lantus – all of which are in Phase III trials.
Positive Phase I data were presented at EULAR for its biosimilar Humira candidate, SB5, while development partner Merck presented positive Phase I data for MK-1293 (also known as SB9), its biosimilar Lantus candidate, at the American Diabetes Association's annual meeting.
While the company has suspended development of biosimilar Rituxan, the combination of its late-stage pipeline alongside two already submitted products puts Samsung Bioepis in a commanding position to overtake Celltrion's early lead.
Assuming the EMA's review follow the average timelines for the previous 10 biosimilar filings since 2004 – calculated by FirstWord’s Biosimilar Index as 18 months – then Samsung Bioepis and its EU commercialisation partner for anti-TNF therapies, Biogen, could receive approvals for SB4 and SB2 in Q2 2016 and Q3 2016, respectively.
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