Large Molecule

Amgen Gets EMA Ok for Humira Biosims

Jan 28, 2017

Regulatory Affairs Professionals Society

The European Medicines Agency (EMA) has recommended the approval of two Amgen biosimilars for AbbVie’s blockbuster Humira, for treatment of inflammatory diseases.

Amgen's Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU, says RAPS.

Amgen’s Humira biosimilar was also approved in the U.S. in September 2016 under the name Amjevita; however patent disputes are predicted to delay the drug's availability on the market.

If approved, marketing authorization will be granted to the two Amgen biosims in the European Union.