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Amgen, Allergan seek US FDA approval for biosimilar of Roche's Rituxan

Amgen Inc. and Allergan PLC filed an application with the U.S. Food and Drug Administration for approval of ABP 798, a biosimilar to Roche Holding AG's and Biogen Inc.'s blockbuster drug Rituxan.

Biosimilars are biological products that act in the same way as their reference products, usually brand-name medicines that have been available on the market for a while. A biosimilar is intended to be a lower-cost version of biologic therapy, a type of treatment derived from living organisms.

The companies' biologics license application for ABP 798 is supported by positive data from two separate studies evaluating the therapy against Rituxan in treating a type of blood cancer — non-Hodgkin lymphoma — and rheumatoid arthritis.

In a Dec. 19 press release, the companies said results from the studies show no clinically meaningful differences between the drugs.

The companies are collaborating on four cancer-treating biosimilar drugs, two of which have been approved by the FDA.

Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S. and three approved in the EU.

Rituxan is approved in many regions for treating adult patients with non-Hodgkin lymphoma; chronic lymphocytic leukemia; microscopic polyangiitis, a type of blood vessel inflammation disorder; and autoimmune disorders such as moderate to severe rheumatoid arthritis, pemphigus vulgaris and granulomatosis with polyangiitis.