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Amgen, Allergan's Biosimilar of Avastin Tops Phase III Study

Amgen Inc.AMGN and Allergan plc AGN announced positive results from a phase III study on their biosimilar candidate, ABP 215. The companies are developing ABP 215 as a biosimilar version to Roche's RHHBY best-selling cancer drug, Avastin (bevacizumab).

The randomized, double-blind, active-controlled study (n=642) was conducted to evaluate the safety and efficacy of ABP 215 in comparison to Avastin, in adults suffering from advanced non-squamous non-small cell lung cancer (NSCLC) receiving first-line chemotherapy with carboplatin and paclitaxel. ABP 215 successfully achieved its primary endpoint of demonstrating clinical equivalence compared to Avastin. In addition, the biosimilar candidate had a comparable safety and immunogenicity profile and met all secondary endpoints.

We remind investors that Amgen is collaborating with Allergan for the worldwide development and commercialization of four oncology biosimilars including ABP 215. Per agreement terms, Amgen is solely responsible for the development, manufacturing and initial commercialization of these products.

We note that Avastin is approved in specific combinations in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications. As per company-reported numbers and Evaluate Pharma (Feb 24, 2015), worldwide sales of Avastin were approximately $7 billion in 2014.

We are encouraged by the positive results on ABP 215. Amgen currently has nine biosimilar candidates in its portfolio representing huge commercial opportunity - annual revenues of more than $3 billion. The company plans to launch its first biosimilar in 2017 followed by four others through 2019.

However, Amgen itself is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved (Mar 2015) biosimilar, was launched by Sandoz earlier this month. Zarxio is the biosimilar version of Amgen's blockbuster drug, Neupogen (filgrastim).

Amgen is a Zacks Rank #3 (Hold) stock. Gilead Sciences, Inc. GILD is a better-ranked stock in the biotech sector carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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