San Fernando Valley Business Journal

Amgen Biosimilar Approved in Europe

By Stephanie Henkel Friday, March 24, 2017

Amgen Inc.’s biosimilar to the best-selling drug of all time has been approved for commercialization by the European Commission, the company announced Thursday.

Amgevita, a biosimilar to pharma giant AbbVie Inc.’s arthritis medication Humira – which brought in over $16 billion in worldwide sales last year – has been approved to treat a number of inflammatory diseases in adults and children, including various forms of arthritis, plaque psoriasis and Crohn’s disease.

“The approval of our first biosimilar by the European Commission is a major milestone not just for Amgen as a company, but for the millions of patients with chronic inflammatory diseases who need alternative treatment options,” Dr. Sean Harper, Amgen’s executive vice president of research and development, said in a statement.

Biosimilars are highly comparable to their original bioengineered counterparts but are not exact replicas because they are made in living cells.

The Thousand Oaks biotech’s version was FDA-approved last September following Chicago-based AbbVie’s lawsuit claiming Amgevita infringed on at least 10 AbbVie patents.

Amgen shares closed Friday down 30 cents, or a fraction of a percent, to $165.74 on the Nasdaq.