EMA's Biosimilar List Includes Drugs Also Under FDA's Scrutiny

Today, the European Medicines Agency (EMA) released its June 2017 list of medicines currently under evaluation, showing 4 applications under review for adalimumab, 2 applications for bevacizumab, 1 new application for infliximab, 1 application for insulin glargine, 3 applications for pegfilgrastim, and 4 applications for trastuzumab.

Since the first of the year, the EMA has approved a number of biosimilar products: January saw the approval of Eli Lilly’s biosimilar to teriparatide (Foresto, Forteo), an osteoporosis drug. In February, Celltrion’s Tuxella (also marketed as Ritemvia, Truxima, and Blitzima), a rituximab (Rituxin) biosimilar, gained approval. March saw the approval of Amgen’s application for its adalimumab (Humira) biosimilar, while Merck marked April with its insulin glargine (Lantus) product.

Europe continues to outpace the United States in biosimilar product approvals; while the FDA was first to approve an adalimumab biosimilar, the EMA’s March approval granted to Amgen means that each originator biologic that has an approved US biosimilar now has a biosimilar approved in Europe. Yet the United States may be starting to catch up with the European marketplace; many of the same applications under review at the EMA are also under review at the FDA. Perhaps most notably, several companies are vying to be first to introduce a pegfilgrastim (Neulasta) biosimilar to the US and European markets.

Coherus submitted its application for pegfilgrastim to the FDA in August of 2016, following applications by Sandoz in 2015 and Apotex in 2014. Sandoz, for its part, suffered a disappointment when the FDA rejected its application for pegfilgrastim biosimilar, and industry reports say that Sandoz’s US product approval may be delayed until 2018. Meanwhile, Sandoz withdrew its application from the EMA. Apotex hopes to beat its competitors to market, and issued a Citizen Petition to the FDA in May asking the agency to require all proposers of pegfilgrastim biosimilars to conduct appropriate studies for their products (noting that Coherus, in particular, has not yet studied its proposed product in any diseased patients for indicated uses).

In addition to applications for pegfilgrastim, both the FDA and EMA are considering biosimilar applications for trastuzumab (Mylan and Biocon), bevacizumab (Amgen and Allergan), and adalimumab (Boehringer Ingelheim).

A newly streamlined approvals process for biosimilars in the FDA may begin to close the gap between the US and European biosimilars approvals; when the FDA approved Samsung Bioepis’s infliximab-abda (Renlexis) in early 2017, it was the first time that a biosimilar product had been approved in the United States without a public advisory committee meeting; the agency indicated that it would hold only 1 such meeting for the first approved biosimilar of a reference product, a move that could speed up the approvals process for future applications.