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Amgen/Allergan File for EU Approval of Avastin Biosimilar

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Amgen Inc. (AMGN - Free Report) , along with partner Allergan plc. , announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, their biosimilar version of Roche Holding AG’s (RHHBY - Free Report) cancer drug Avastin (bevacizumab). ABP 215 is the most advanced oncology biosimilar candidate in Amgen’s pipeline.

Amgen shares gained 3.5% in the past one month, comparing favorably with an increase of 3.1% for the Zacks classified Medical-Biomed/Genetic Market.



Last month, the companies filed a Biologics License Application (BLA) to the FDA for ABP 215.

Note that Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of the former’s oncology antibody biosimilar medicines.

The MAA submission was based on data from a phase III comparative efficacy, safety and immunogenicity study, which evaluated adult patients with non-squamous non-small cell lung cancer (NSCLC). The study confirmed no clinically meaningful difference between ABP 215 and bevacizumab in terms of efficacy, safety and immunogenicity.

We note that Amgen has a total of nine biosimilar candidates in its portfolio, which includes Amjevita, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) Humira. Amjevita was approved by the FDA this September. Those currently under development include the biosimilar versions of Roche’s Rituxan, Eli Lilly’s Erbitux, and Johnson and Johnson/Merck’s Remicade. Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan. The company plans to launch the first biosimilar in 2017, followed by four others through 2019, subject to successful approval.

According to sources, the market for biosimilars can grow to $20 billion in 2020. Not surprisingly, competition in this space is intensifying with the number of pharmaceutical and biotech companies working on biosimilars growing by the day.

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