AMGN Amgen Inc

By Maria Armental 

U.S. regulators cleared for sale a knockoff version of Johnson & Johnson's Remicade anti-inflammatory drug, the second entry in a fledgling U.S. market for lower-cost copies of pricey biotechnology drugs.

The U.S. Food and Drug Administration said Tuesday it approved Inflectra, which was developed by Korea's Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, inflammatory bowel diseases and other conditions.

Inflectra is what regulators and the drug industry call a "biosimilar" to J&J's Remicade, which has been available since 1998 and had U.S. sales of $4.45 billion last year. A biosimilar is a close copy of a biotech drug, which is usually manufactured in living cells rather than synthesized chemically like traditional pills.

The FDA last year approved the first biosimilar -- a Novartis AG version of Amgen's Neupogen drug for cancer chemotherapy patients -- using new criteria arising from a provision of the 2010 Affordable Care Act aimed at supporting a biosimilar market. Now the FDA is considering additional biosimilar applications, including those for some of the biggest-selling biotech brands.

But the road to market for U.S. biosimilars hasn't been smooth and may not generate the degree of cost savings that some expected. J&J and other makers of brand-name biotech drugs have sought to block biosimilars from the market by asserting patent rights for their drugs. The Neupogen biosimilar from Novartis didn't become available until about six months after FDA approval -- following legal wrangling between Amgen and Novartis -- and at just a 15% discount to the brand price.

It isn't clear when Inflectra will hit the market. J&J sued Celltrion in federal court in Massachusetts last year, alleging the Celltrion drug would infringe six patents for Remicade, including one that was issued in 2009 and expires in 2027. The patent covering the drug's composition is due to expire in 2018. Celltrion denied the infringement allegations.

Pfizer, which holds the U.S. marketing rights to the Celltrion biosimilar, said Tuesday it is "continuing with the preparation of our launch plans for 2016." But the company said the timing will depend upon "marketplace dynamics and intellectual property considerations."

J&J said Tuesday Inflectra is "not identical" to Remicade, and that the FDA didn't approve Inflectra to be interchangeable with Remicade.

A Celltrion spokeswoman referred questions to Pfizer.

AbbVie, which is facing a looming threat of competition for the arthritis treatment Humira, said it has taken out about 70 patents for the drug, one of the largest patent portfolios ever assembled for a single drug. The drug's primary U.S. patent is due to expire in December, but AbbVie says the additional patents should keep copycat versions of Humira off the U.S. market until at least 2022.

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

April 05, 2016 18:25 ET (22:25 GMT)

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