- Samsung Bioepis Co., Ltd. has won EU approval for its biosimilar version of AbbVie's top-selling Humira, making the Korean drugmaker the first company to secure regulatory OK in Europe for copies of all three major anti-TNF biologic medicines.
- The company had previously secured approval in Europe for copies of Amgen's Enbrel and of Remicade, which is marketed by Merck & Co. in the region but sold by Johnson & Johnson in the U.S.
- Biosimilar development is more advanced in Europe than it is in U.S. and some biologic makers have already seen sales erosion due to the presence of cheaper copies. Sales of Remicade, for example, have steadily eroded since 2014 and Merck expects further declines to continue.
Samsung Bioepis' is only the second company to have won approval in either the U.S. or Europe for Humira (adalimumab), which has consistently been one of the world's top-selling drugs for the past several years.
EU authorization is further evidence of Samsung Bioepis' rapid development into one of the leading companies in the biosimilar field. Founded five years ago as a joint venture between Samsung, Inc. and Biogen, Inc, the company has quickly scaled up operations, partnering with both Biogen and Merck to commercialize its approved biosimilars.
Biogen is responsible for marketing all three of the anti-TNF inhibitors in Europe, while Merck sells the Remicade (infliximab) biosimilar in the U.S.
Having found success on the biosimilar front, Samsung Bioepis just announced an ambitious bid to take on development of original biologic medicines — a riskier, and likely costlier endeavor. For now, its efforts in pursuit of novel drugs will be in partnership with Japanese drugmaker Takeda Pharmaceuticals Company. The two companies plan to first focus on a candidate for severe acute pancreatitis but the deal's scope covers other as yet undisclosed targets.
Biosimilars are not without risk, however. The process of creating a highly similar version of a biologic drug is substantially more complex than developing a generic pharmaceutical. Costs are higher and the regulatory framework for the drugs in the U.S. is only just beginning to mature.
Yet, with many of the world's best-selling biologics nearing the end of their patent lives, drugmakers both large and small have seen an opportunity to win a slice of what are often billion-dollar revenue streams. Humira, Enbrel (etanercept) and Remicade are some of the most high-profile drugs for inflammatory diseases like rheumatoid arthritis or plaque psoriasis.
Others, such as Roche Holding AG's trio of cancer biologics, look set to be targeted next. Samsung Bioepis has filed for approval in the EU for a version of the Swiss pharma's Herceptin (trastuzumab), which also faces threats in the U.S. from Mylan N.V. and the team at Amgen and Allergan.