FDA Gives Approval to Knockoff for Rheumatoid

The U.S. Food and Drug Administration has cleared the sale of a knockoff of Remicade the Johnson & Johnson anti-inflammatory drug, the second treatment in the fledgling market in the U.S. for less expensive copies of biotechnology high-priced drugs.

The FDA announced this week it had approved Inflectra a drug developed by Celltrion Inc based in South Korea and licensed to Pfizer, for the treatment of inflammatory bowel diseases, rheumatoid arthritis and other types of conditions.

Inflectra is what the drug industry and regulators call a biosimilar to Remicade, which since 1998 has been in the market and last year had sales in the U.S. of $4.45 billion.

A biosimilar drug is a close copy of an original biotech drug that is manufactured usually inside living cells instead of being synthesized chemically as are traditional pills.

Last year, the FDA approved its first biosimilar, which was a Novartis version of Neupogen from Amgen the drug for chemotherapy patients.

A provision in the Affordable Car Act of 2010 is aimed at giving support to biosimilars being in the market.

Now U.S. regulators are considering more biosimilar applications such as those for some of the largest selling brands of biotechs.

However, it has not been a smooth road for biosimilars in the U.S. to market and might not generate the amount of cost savings some had come to expect.

Johnson & Johnson as well as other brand name biotech drug makers have sought to have the biosimilars blocked from the U.S. market through asserting their patent rights for the drugs.

The biosimilar for Neupogen from Novartis did not become available until close to six months after approval by the FDA following a legal battle between Novartis and Amgen and a only a 15% discount below the branded price.

It is not clear the date that Inflectra will reach the market as Celltrion was sued by Johnson and Johnson last year in federal court alleging the drug by Celltrion would be infringing on six different patents held by Remicade.

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