Samsung Bioepis seeks approval of Humira biosimilar in Europe

Samsung Bioepis, the biopharma development unit of South Korean tech giant Samsung Group, said Monday it is seeking regulatory approval to sell its biosimilar drug referencing AbbVie’s top-selling rheumatoid drug Humira (adalimumab) in Europe.

The Samsung unit said the European Medicines Agency has accepted for review the company’s marketing authorization application for its Humira biosimilar, SB5, drawing a step closer to commercializing the drug in the region.

SB5 is Samsung Bioepis’ third biosimilar candidate submitted to the EMA. Its Enbrel biosimilar and Remicade biosimilar were already approved by the agency in January and May of this year, respectively, and have begun sales in a number of countries in the region.

“If approved, SB5 will join (its Enbrel biosimilar) Benepali and (its Remicade biosimilar) Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending,” Samsung Bioepis president and CEO Ko Han-sung said in a statement.

Biosimilars refer to near-replicas of complex, biologic drugs based on living cells which have lost patent protection. Big name pharmaceutical giants, as well as newcomers like Samsung Bioepis, have been developing biosimilars to steal away a share of the profits enjoyed by the original makers of the world’s blockbuster biologic drugs like Humira.

Exactly when Samsung Bioepis will commercialize its Humira biosimilar remains uncertain, as AbbVie has been filing new patents on Humira to push back the onset of biosimilar competition.

Humira is AbbVie’s top-valued drug, having generated sales of $14 billion last year. AbbVie’s main formulation patent on the drug is slated to expire in Europe in October 2018.

Earlier in March, Samsung Bioepis and its partner and minority shareholder Biogen filed a suit in the U.K., challenging some of the new patents that have been filed by AbbVie.

Some dozen other companies including Japan-based Fujifilm Kyowa Biologics, Coherus Biosciences and Boehringer Ingelheim have reportedly filed similar suits challenging the validity of AbbVie’s innovator patents in Europe and the U.S.

By Sohn Ji-young (jys@heraldcorp.com)