Samsung BioLogics has begun making biosimilar versions of Enbrel and Remicade for its joint venture Samsung Bioepis, the Korean press reports.
South Korean news portal BusinessKorea reported recently that contract development and manufacturing organization (CDMO) Samsung BioLogics has begun pilot production of two products on behalf of customer and joint venture entity Samsung Bioepis.
The project sees the firm produce small scale amounts of Benapali and Flixabi, versions of Amgen’s Enbrel (etanercept) and J&J’s Remicade (infliximab) both approved across numerous markets, and according to the report is the first foray into biosimilar manufacture by Samsung BioLogics.
Samsung Bioepis – a joint venture between Samsung BioLogics and Biogen – offered no comment on this report when contacted by BioProcess Insider.
And while the CDMO itself was unable to disclose any information about its clients, a spokesperson confirmed it has an ongoing contract with Bioepis inked in April 2016. The product Benapali was identified as the firm’s main product in its approval to list on the South Korea KOSPI exchange in 2016.
In June, Biogen upped its stake in Samsung Bioepis to 49.9% through an investment of around US$700 million.
Capacity for biosimilars
Samsung BioLogics has invested heavily in fixed, stainless steel bioreactor capacity at its site in Songdo, Incheon, and according to the spokesperson biosimilar contracts “will be helpful to utilize our facility.”
Facility number one boasts 30,000 L of capacity. A second plant – which received its first US FDA approval last October – houses 150,000 L, consisting of ten stainless steel vessels supplied by Swiss firm Bioengineering AG, plus 2,000 L of single-use capacity.
A third facility will add 180,000 L more capacity and is set to be the largest single biomanufacturing facility in the world once validation is complete, expected later this year.