Catalent to work with Samsung Bioepis on biosim production
- Major contractor Catalent has inked a deal to provide fill-finish production services for the Korean biosimilar developer Samsung Bioepis, the company announced Tuesday.
- More specifically, Catalent will support the commercial supply of SB4, Bioepis' biosimilar of Enbrel (etanercept). The work will take place at Catalent's pre-filled syringe facility in Brussels, Belgium.
- SB4 was the first Enbrel biosimilar approved in Europe, where it is marketed as Benepali by Biogen. The copycat biologic has also gotten a green light from regulators in South Korea, Australia and Canada. Merck Sharp & Dohme sells the drug in those locations, where it is called Brenzys.
The biosimilars market is growing in importance, particularly as cost pressures on healthcare systems increase, and as people demand cost-effective access to biologics.
Markets and Markets, a research firm, predicts a compounded average annual growth rate of more than 20% over the next four years, pushing the global market value to $6.22 billion by 2020, up from $2.29 billion in 2015.
Europe has been at the forefront of biosimilar development. According to QuintilesIMS, there are 23 biosimilars currently approved in Europe, based on eight originator products. Among EU5 countries, the biosimilars market tipped the scales at $490 million in total value last year, the firm said.
Samsung Bioepis has a deep pipeline of biosimilar candidates, including six in a first "wave" that the Korean company is working to roll-out in the U.S. and Europe.
For most biosimilar candidates targeted for Europe, Samsung Bioepis has partnered with Biogen for commercialization, while Merck & Co. is marketing the drugs in geographies outside Europe.
While the U.S. has been slower to pick up on biosimilars, with just four approved so far, this will likely grow as more biologics face patent expiry there. And with that uptake, demand for contract services could also see a pick-up, particularly as biologics manufacturing is typically more complex and involved.
- Catalent Statement
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