Blog Big Molecule Watch November 25, 2015

Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab).

As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. SandozAmgen v. Hospira, and Amgen v. Apotex.  This is the first time Amgen has formally appeared on the BPCIA stage as a biosimilar applicant.

We’ll be sure to cover any further developments on this story here on the Big Molecule Watch.