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Pfizer's (PFE) Biosimilar of Remicade Receives FDA Approval

Pfizer Inc. PFE announced that the FDA has approved Inflectra, a biosimilar version of Johnson & Johnson’s JNJ Remicade (infliximab).

Inflectra received the nod for all approved indications of Remicade including the treatment of rheumatoid arthritis, ulcerative colitis in adults, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease in both adult and pediatric patients.

The approval did not come as a surprise as the FDA’s Arthritis Advisory Committee has already recommended an approval for the biosimilar by a vote of 21 to 3, earlier this year.

Inflectra is the second biosimilar to be approved in the U.S. In 2015, Novartis AG’s NVS generic arm, Sandoz, gained approval for Zarxio, a biosimilar of Amgen’s AMGN Neupogen.

Pfizer stated that it is currently preparing to launch Inflectra in 2016, which depends on marketplace dynamics and intellectual property considerations.

We remind investors that Inflectra was added to Pfizer’s portfolio after its acquisition of Hospira in 2015. Hospira had entered a cooperation agreement with Celltrion in 2009 for several biosimilars including a biosimilar of Remicade. Consequently, Pfizer now owns exclusive commercialization rights to Inflectra in the U.S. and certain other jurisdictions.

We note that in Feb 2016, Sandoz acquired the rights to develop and commercialize the biosimilar version of Remicade in the European Economic Area (EEA) from Pfizer.

Under the terms of the agreement, Sandoz has rights to Inflectra in all 28 countries of the EEA, while Pfizer retains the commercialization and manufacturing rights to the product in all countries outside the EEA.
 
Meanwhile, Sandoz intends to complete the clinical study program on the biosimilar version of Remicade, which includes a global phase III study, REFLECTIONS (B537-02), to evaluate the safety and efficacy of Inflectra and Remicade, in combination with methotrexate, in patients with active rheumatoid arthritis, who have had an inadequate response to methotrexate. Sandoz will file for regulatory approval to the European Medicines Agency and for its registration with the European Commission.

Pfizer currently has a Zacks Rank #3 (Hold). Johnson & Johnson, with a Zacks Rank #2 (Buy), is a better-ranked stock in the health care sector.

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PFIZER INC (PFE): Free Stock Analysis Report
 
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
 
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
 
AMGEN INC (AMGN): Free Stock Analysis Report
 
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