Boehringer Ingelheim’s biosimilar candidate to Humira accepted for review by FDA and EMA

Boehringer Ingelheim today announced that its adalimumab biosimilar (biosimilar to Humira) has been accepted for regulatory review by the FDA and the EMA (European Medicines Agency).

This is the second biosimilar candidate to Humira that FDA has accepted for regulatory review.  The first, Amgen’s application for its Amjevita (adalimumab-atto) biosimilar product, was approved on September 23, 2016.  That product is currently the subject of litigation in Abbvie v. Amgen. Amgen has also submitted a marketing authorization application for a biosimilar candidate to Humira to the EMA.

Stay tuned for further developments on the Big Molecule Watch.