Amgen Inc. (AMGN) and Allergan PLC (AGN) submitted a marketing authorization application to the European Medicines Agency for their cancer biosimilar drug ABP 215.

The ABP 215 marketing application was accompanied by data from a Phase 3 study of adults with non-squamous non-small cell lung cancer. The biosimilar did not show any clinically meaningful difference from Avastin for efficacy, safety and immunogenicity during the Phase 3 trials.

Last month, Amgen and Allergan submitted a biologics license application to the U.S. Food and Drug Administration (FDA) for the Avastin biosimilar. (For more, see Amgen, Allergan Unveil Avastin Copycat.)

A biosimilar is an approved drug that it is highly similar to an FDA-approved biologic product, and has no clinically meaningful difference in safety or effectiveness from the original product. (For more, see Amgen Targeting Biosimilars.)

Avastin's YTD Sales Top $5 Billion

Amgen and Allergan's ABP 215 drug is a biosimilar of Genentech Inc.’s blockbuster Avastin (bevacizumab) cancer drug. Genentech is a unit of Roche AG (RHHBY). 

Avastin has secured seven different approvals for treating various cancers in the United States. Avastin is also approved in the EU and other regions of the world for treating cancer of the colon, kidney, ovarian and breast. 

Avastin generated around $5 billion in sales during the first nine months of 2016. The patents on Roche’s Avastin drug are valid in the U.S. until July 2019 and in Europe until January 2022.

15 Avastin Biosimilars Being Developed

The marketing approval, once secured, will enable Amgen and Allergan to cash in on the large EU cancer drug market.

However, they have plenty of competition, as 15 biosimilars of Avastin are reportedly under development.

Amgen and Allergan believe their submission is the first bevacizumab biosimilar application submitted to the European Medicines Agency.

The two companies are jointly developing three more oncology biosimilar drugs. ABP 215 works by binding to vascular endothelial growth factor, which prevents the formation of new blood vessels that fuel the growth of solid cancers.

Amgen has been advancing its biosimilars program rapidly with its Humira biosimilar, Amjevita, which secured an FDA nod in September 2016, but may need to wait on regulatory hurdles. (For more, see Long Wait for Biosimilar Amjevita.)

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