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Pfizer Gets FDA's Approval on Cheaper Arthritis Drug,' Inflectra'

Update Date: Apr 08, 2016 05:43 AM EDT
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The Food and Drug Administration approved the less-expensive drug called Inflectra. The agency approved Pfizer's and Celltrion's Inflectra as a biosimilar to arthritis treatment, Remicade of Johnson & Johnson's.

According to Bloomberg BNA, Food and Drug Administration approval approaches a year ago after the agency accepted the first U.S. biosimilar that can be used as a cancer treatment from biologics Price Competition Innovation Act (BPCIA).The first U.S. biosimilar was similar to Sandoz's biosimilar of Amegen called Zarxio.

A statement from Stacie Ropka to Bloomberg BNA, "This signals that the Food and Drug Administration has confidence in its approval process and confidence to okay something as complex as a biosimilar of a monoclonal antibody as well as extrapolations across seven indications of the original biologic or reference product.

The Zarxio is a biosimilar of a straightforward protein as Remicade, having seven indications. Remicade produces $4.5 billion in the United States sales in 2015 for Johnson and Johnson's, against AbbVie Inc.'s Humira. FDA accepts the biosimilar version of Humira from Amgen Inc.

According to Ropka, FDA knows the required data for biosimilar cases for both complex biologics and straight-forward. She thinks that there are no regrets on the case since it opens a big step forward to biosimilar developers' and encourage others to do so.

The President and Chief executive officer of the Pharmaceutical Care Management Association (PCMA) said that FDA is taking an important role towards accepting more biosimilar medicine in the United States. It increases the competition between approved biosimilar brands to the generic drug by lowering the prescription drug cost for employers and consumers.

A biosimilar is analogous but has no similarity to generic drugs, while biologic is a complex, large molecule like a monoclonal antibody. The generic drug is identical to the original drugs, it's a product that designed to resemble an FDA-approved as biologically similar to reference product with no clinical difference. It is also interchangeable without any acceptance of any physician.

Recent news from Pharmaceutical Processing, a head of global biosimilar at Pfizer Incorporated named Jenny Alltoft said, "Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,'"Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible."

The Second U.S. biosimilar drug, Inflectra, is assigned for the treatment of people with a serious autoimmune disease such as Crohn's disease, uncreative colitis, ankylosing spondylitis and plaque psoriasis. 

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