Regulatory News

EMA Recommends Two Amgen Humira Biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab).

Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU. Humira was first authorized in the EU on 8 September 2003.

The EMA recommendations were announced on the same day AbbVie announced Humira sales of $16 billion worldwide for 2016, which comes on top of $14 billion for 2015, more than $20 billion from 2014 and 2013 and has been a blockbuster since 2005.

In the EU, the biosimilar Amgevita is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis and uveitis.

Solymbic is intended to treat rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. The CHMP positive opinions will now be reviewed by the European Commission (EC).

Amgen’s Humira biosimilar was also approved in the US in September 2016, and is known as Amjevita (adalimumab-atto), though some say patent disputes could delay the biosimilar’s marketing in the US until 2018 or 2019.

More than a dozen other companies, including a joint venture between Samsung Biologics and Biogen, Boehringer Ingelheim, Momenta Pharmaceuticals and Sandoz are also developing Humira biosimilars.

In India, Zydus Cadilla in December 2014 launched its version of the biologic and published its Phase III data in July 2015. Torrent Pharmaceuticals also launched its adalimumab biosimilar in India last year.