Panel Recommends FDA Approval of Remicade Knockoff

Pharmaceutical industry analysts expect Pfizer to sell the drug, to be sold under the brand name Inflectra, at a discount to Remicade and similar biotech drugs used to treat autoimmune diseases.

Based on the biological similarity of the infliximab biosimilar to the innovator product, the FDA panel endorsed its use for all of the indications sought by Celltrion: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. The panel will decide whether to recommend approval of Remsima to treat rheumatoid arthritis and inflammatory bowel conditions like Crohn’s disease. In prepared remarks, Siegel said Pfizer and Celltrion’s clinical data “do not adequately address residual uncertainty regarding use in IBD”, as the biosimilar was never compared directly with Remicade in either disease. Given yesterday’s Advisory Committee recommendation, FDA marketing approval for this biosimilar is possible as early as April 2016. The drug is the biosimilar version of Amgen’s Remicade, which has brought billions of profits for the company. The FDA usually, but not always, follows the advice of its advisory panels.

Johnson & Johnson’s USA sales for Remicade were $4.45 billion past year, the Journal adds. In the U.S., Pfizer has exclusive rights to the biosimilar so will have the market to itself until other companies get their knockoffs approved. Humira, the highest-selling prescription drug in the world, generated $14 billion in global sales previous year, more than 60% of AbbVie’s total revenue.

Celltrion CEO HyoungKi Kim said: “Given that this would be the first biosimilar monoclonal antibody to be approved in the US, thisAdvisory Committee meeting is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments”. The committee concluded that CT-P13 is highly similar to Remicade, notwithstanding minor differences in clinically inactive components.

Generics are interchangeable with the original drugs.

J&J sued Celltrion in federal court in MA past year, alleging the Celltrion drug would infringe upon six patents for Remicade, including one that was issued in 2009 and expires in 2027. The company says it has “seen numerous late-filed patents that appear to have no other goal than delaying the market entry of biosimilars”.

After Johnson & Johnson, AbbVie might be the most vulnerable to a decline in sales from the FDA’s approval of the Remicade biosimilar.

The drug is also only the second biosimilar to be approved in the U.S. after Novartis/Sandoz’ Zarxio (filgrastim-sndz), which is a copy of Amgen’s white cell stimulator Neupogen (filgrastim).

Although AbbVie has secured more than 70 new patents on Humira’s antibodies and different formulations, extending its patent protection till 2022-2034, sales seem to be at risk with threat from biosimilars for other anti-inflammatory drugs.