FDA Advisory Committee Recommends Pfizer’s Biosimilar of Remicade

The US Food and Drug Administration's (FDA) Arthritis Advisory Committee has recommended to approve Pfizer’s investigational biosimilar, infliximab, across all eligible indications by a vote of 21 to three. Celltrion’s proposed biosimilar infliximab, to which Pfizer holds exclusive US commercialization rights, is the first biosimilar monoclonal antibody therapy to be reviewed by the FDA for licensure in the US and is only the second biosimilar to be recommended for approval by a US FDA Advisory Committee, according to Pfizer. In 2015, the FDA approved Sandoz’s Zarxio (filgrastim-sndz), the first biosimilar product approved in the United State, which is based on the reference product, Neupogen, marketed by Amgen,

Hospira, now a Pfizer company following Pfizer’s $17 billion acquisition of Hospira in 2015, entered into a business cooperation agreement with Celltrion in 2009 for several biosimilar products, including a potential biosimilar to Remicade (infliximab). Pfizer has exclusive commercialization rights to the proposed biosimilar infliximab in the US and certain other jurisdictions.

Remicade was the first anti-tumor necrosis factor (TNF)-alpha treatment approved in the United States in August 1998. Janssen Biotech, Inc. part of Johnson & Johnson (J&J), discovered and developed Remicade and markets the product in the United States. In 2015, the product posted global sales of $6.6 billion and US sales of $4.5 billion for J&J. 

The Janssen Pharmaceutical Companies, also part of J&J, market Remicade in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Remicade to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to Remicade to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.

In separate news, Sandoz, the generics arm of Novartis, announced that it was acquiring European rights to the biosimilar of infliximab, Pfizer had to divest its European rights as a term of the European Commission’s approval for its acquisition of Hospira.

Sandoz acquired from Pfizer the rights for the development and commercialization of the investigational biosimilar infliximab in the 28 countries that form the European Economic Area (EEA). Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency. Sandoz has biosimilar programs in various stages of development and regulatory filing, including biosimilars adalimumab and etanercept that, like infliximab, are TNF-α medicines. The company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the FDA.

The FDA is considering Pfizer’s proposed biosimilar infliximab for all indications of the reference product eligible for licensure, including the treatment of rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn's disease.

The FDA is not bound by the advisory committee's recommendation, but the agency takes its advice into consideration when reviewing the biologics license application for medicinal products. If approved, Pfizer plans to launch the product this year.

Source: Pfizer and Sandoz

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