Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Biosimilar News  •  BPCIA and Related U.S. Statutes

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.

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