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. Sandoz, Amgen 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.