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Pfizer's Second Biosimilar of Remicade Receives FDA Approval

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Pfizer Inc. PFE announced that the FDA has approved Ixifi its second biosimilar version of Johnson & Johnson's JNJ blockbuster rheumatoid arthritis (“RA”) drug, Remicade (infliximab). Notably, Ixifi is a chimeric human-murine monoclonal antibody against tumor necrosis factor.

Ixifi received the nod for all approved indications of Remicade including RA, ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease.

Shares of Pfizer have risen 12.8% so far this year, underperforming the industry’s rally of 17.7%.

The approval was based on an encouraging data from phase III study, REFLECTIONS B537-02. A biologics license application was filed with the FDA in April.

Notably, in February 2016, Pfizer had divested the rights to development, commercialization and manufacturing of Ixifi in the European Economic Area (“EEA”) to Novartis' generic arm, Sandoz. However, Pfizer retains the commercialization and manufacturing rights to Ixifi in all countries outside the EEA.

We remind investors that Pfizer’s first biosimilar product to Remicade, Inflectra, was launched last November in the United States. The company has exclusive commercialization rights to Inflectra in the United States and on certain other territories.

In September, Pfizer filed a lawsuit in a U.S. district court alleging that J&J is resorting to unfair practices to prevent the sale of Inflectra, available at a Wholesale Acquisition Cost, which is 19% lower than J&J’s referenced product.

Pfizer alleged in a complaint filed in the U.S. District Court for the Eastern District of Pennsylvania that J&J has entered into biosimilar-exclusion contracts with U.S. insurers. These contracts boost insurers not to cover Inflectra, thus making it difficult to access by patients and protecting its referenced product.

Pfizer also claimed that anticompetitive contracts with discounts were offered to hospitals on purchase of Remicade on condition that they do not buy the biosimilar versions. Pfizer claims that these unfair practices benefit sales of J&J’s referenced product, a key revenue generator for the latter.

Pfizer is evaluating 13 biosimilar molecules in various stages of development. Biosimilar products in late-stage development include biosimilar versions of Roche's RHHBY Rituxan and Avastin and AbbVie's ABBV Humira. A biosimilar version of Herceptin is under review in the United States and the EU. In Europe, Pfizer markets Nivestim, biosimilar versions of Amgen’s Neupogen and Retacrit as well as biosimilar versions of Amgen’s Epogen.

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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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