EMA accepts adalimumab biosimilar applications from Fujifilm Kyowa Kirin and Sandoz, and an infliximab biosimilar application from Sandoz

Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates.

Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that on May 18, 2017, the EMA accepted its application for FKB327, an adalimumab biosimilar candidate to AbbVie’s HUMIRA product.   According to the press release, Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation and Kyowa Hakko Kirin Co., Ltd. on March 27, 2012 to develop, manufacture, and market biosimilars.

Sandoz, a Novartis division, has announced that on May 31, 2017, the EMA accepted its MAA for biosimilars to HUMIRA (adalimumab) and Janssen’s REMICADE (infliximab) product.  Sandoz noted that it is seeking approval for biosimilar adalimumab and infliximab for use in all indications approved for the respective reference product.  Novartis has stated that Sandoz has “five major biosimilar launches planned in the EU and US between now and 2020.”