The Incheon, Korea headquartered firm – a joint venture between South Korean conglomerate Samsung and Switzerland’s Biogen – is seeking approval for a number of biosimilars in various markets, including Europe.
Last month, the European Medicines Agency’s (EMA) Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that Benepali, a biosimilar version of Amgen’s Enbrel (etanercept), be approved in Europe.
Spokesman Mingi Hyun told us: "Samsung Bioepis UK was established to support our operations in Europe.”
He added that: “One of SBUK's primary responsibilities will be to act as Samsung Bioepis' market authorization holder (MAH) upon approval of our biosimilar products in the European Union."
However, if Benepali or any of the other biosimilars Samsung Bioepis is developing is approved by European regulators, Biogen will be responsible for selling it according to spokeswoman Shannon Altimari.
She confirmed that: “Bioepis is the MAH for all the anti-TNF biosimilars we partner on here in Europe. Biogen is the commercialization leads here for all three anti-TNFs, Benepali, SB2 and SB5.”
Complex commercialization deal
Biogen will also sell the Enbrel biosimilar in Switzerland, and Japan, while Merck & Co. (known as MSD outside North America) will commercialise the biosimilar in all other markets, excluding the US.
The drug was recently approved in Korea and Merck & Co is expected to launch it before the end of the year.
Merck will also be responsible for selling Renflexis, Samsun Bioepis's biosimilar version of J&J’s Remicade (infliximab), in Korea.
Merck & Co sells the originator drug in Europe, Russia and Turkey under a 2011 deal with J&J.
IPO: no comment
In July Samsung Bioepis told us it was considering an IPO on the NASDAQ Stock Exchange to raise cash to fund the development of biosimilar products.
We asked the firm if the plan is still on track, however, a spokesman told us “We are unable to comment at this time."