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Pfizer's Humira Biosimilar Meets Primary Endpoint in Study

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Pfizer, Inc. (PFE - Free Report) announced positive top-line results from the comparative REFLECTIONS B538-02 study on its investigational compound, PF-06410293, a potential biosimilar to AbbVie Inc.’s (ABBV - Free Report) Humira (adalimumab) approved for the treatment of patients with rheumatoid arthritis.

Pfizer’s three-month share price movement shows that the stock has significantly outperformed the Zacks classified Large Cap Pharma industry. Specifically, the company gained 0.2%, while the industry lost 4%.



Coming back to the latest news, REFLECTIONS B538-02 is a comparative safety and efficacy study on PF-06410293, in combination with methotrexate, compared with a combination of Humira and methotrexate, in patients with moderate-to-severe rheumatoid arthritis. Data from the study showed that the primary endpoint of the American College of Rheumatology 20 (ACR20) response rate was equivalent for PF-06410293 and Humira.

Humira, which is currently approved for several indications, generated sales of $14 billion in 2015, up 11.7% year over year.

We remind investors that Amgen, Inc.’s (AMGN - Free Report) biosimilar version of Humira, Amjevita, received FDA approval in Sep 2016. However, Amgen does not expect to launch Amjevita in 2017 due to an ongoing litigation with AbbVie.

Pfizer's biosimilar portfolio got a significant boost from the company’s Hospira acquisition in 2015. The company expects to launch Inflectra, a biosimilar version of Johnson & Johnson (JNJ - Free Report) and Merck’s blockbuster drug, Remicade, in the U.S. shortly. Inflectra is the first and only biosimilar monoclonal antibody (mAb) therapy, and the second biosimilar to be approved in the U.S.

Pfizer’s pipeline consists of eight distinct biosimilar molecules in mid- to late-stage development, apart from several others in earlier stages.

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

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Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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