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Pfizer’s Herceptin Biosimilar Meets Primary Endpoint in Study


Pfizer, Inc. PFE recently announced that its experimental biosimilar of Roche Holding AG’s RHHBY breast cancer drug – Herceptin – has reached the primary endpoint in a pivotal study.

Pfizer shares rose 1.4% in November, comparing favorably with a decline of 0.3% for the Zacks classified Large-Cap Pharma industry.

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Coming back to the latest news, REFLECTIONS B3271002 study is a comparative safety and efficacy study of PF-05280014 in combination with paclitaxel versus a combination of Herceptin and paclitaxel in first line patients with HER2-positive metastatic breast cancer. Data from the study showed that the primary endpoint of objective response rate (ORR) was equivalent for PF-05280014 and Herceptin

Roche’s Herceptin generated sales of CHF 6.5 billion in 2015 – more than 13% of the company total sales.

We note that Pfizer's biosimilar capabilities were significantly boosted by the Hospira acquisition in 2015. The company is expected to launch Inflectra, a biosimilar version of Johnson & Johnson JNJ/ Merck & Co., Inc.’s MRK blockbuster drug Remicade in the U.S. soon. Inflectra is the first and only biosimilar monoclonal antibody (mAb) therapy and the second biosimilar to be approved in the U.S.

Other than Herceptin, Pfizer’s biosimilars in late-stage development include biosimilar versions of Roche’s Rituxan and Avastin, and AbbVie’s Humira.

Pfizer believes that the market for biosimilars is huge and can grow to $17–$20 billion by 2020.In the third quarter of 2016, Pfizer recorded biosimilars revenues of $83 million.

In fact, the pharmaceutical industry is awaiting a string of biosimilars, which are essentially generic versions of expensive biologic drugs.

Several pharma as well as biotech companies are involved in the development of biosimilars. The first biosimilar to gain approval in the U.S. was Sandoz’s Zarxio, a biosimilar version of Amgen’s Neupogen. Zarxio was launched in the U.S. in Sep 2015.

Other approved biosimilars in the U.S. include Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept). Amgen’s Amjevita is an approved biosimilar version of Abbvie’s Humira. However, these have not been launched yet.

Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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