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Remicade Patent Infringements Denied: Opens Door for New Biosimilars

Aug 18, 2016 1:09 pm

A U.S. court has affirmed its decision that the patent for Johnson & Johnson's drug Remicade is invalid. This new ruling favors the intent of Celltrion and Pfizer, who are seeking to bring their biosimilar versions of infliximab to market in the near future.

Remicade has been Centocor's (J&J's) best selling product, with $6.6 billion in sales last year. The drug's patent will lapse in September 2018.

Celltrion and Hospira received FDA regulatory approval in April 2016 for its biosimilar Inflectra. Pfizer's product is currently under review and regulatory approval is expected in the next few months.

In response to the introduction of these biosimilars, J&J filed a lawsuit against Celltrion and Pfizer seeking a declaratory judgment that their biosimilar product infringes several of its patents.

J&J intends to appeal the latest court decision.

The author has received compensation as an advisor or consultant on this subject

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