FRANKFURT (Reuters) - European regulators have recommended approval of a second copy of AbbVie’s rheumatoid arthritis drug Humira, the world’s top-selling medicine, in a further boost for so-called biosimilars in the region.
The European Medicines Agency said on Friday its experts had backed the latest copy of the drug from South Korea’s Samsung Bioepis, which specializes in making cheaper copies of complex biotech drugs known as biosimilars.
The EU Commission, which has the final word on drug approvals in the region, typically follows the experts’ advice.
Amgen won European approval for the first copy of the drug, also called adalimumab, in March.
These green lights clear the way for biosimilar copies of Humira to be launched in Europe in due course, although lawyers do not expect this to happen before October 2018, given the patents protecting adalimumab.
Samsung Bioepis, an unlisted unit of South Korean conglomerate Samsung Group [SAGR.UL], already sells biosimilar copies of two other rheumatoid arthritis drugs, Remicade and Enbrel, in Europe.
It will market its version of Humira under the brand name Imraldi.
While the company has yet to turn a profit since it was formed in 2012, Samsung Group hopes the biosimilars’ maker will eventually emerge as a new growth engine for the smartphones-to-shipbuilding conglomerate.
Bioepis is 94.6 percent owned by contract drugmaker Samsung Biologics. U.S. biotech group Biogen is also a minority shareholder.
Reporting by Ben Hirschler and Ludwig Burger; Editing by Adrian Croft