The US District Court for the District of MA on Thursday officially ruled Janssen’s main formulation patent on its blockbuster rheumatoid arthritis drug Remicade invalid, making way for the entry of biosimilars to the US market. A U.S federal judge on Wednesday (local time in the U.S) invalidated the key patent of J&J’s blockbuster arthritis and autoimmune drug Remicade, giving legal go-ahead to Celltrion to market Remsima, biosimilar or low-priced replication, of J&J’s steady seller Remicade.
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Remicade brought in sales of $2.9 billion (including US exports) in the U.S.in the first six months of 2016 and $4.5 billion (U.S.) in 2015. Pfizer is seeking a big slice of that pie after having won Food and Drug Administration approval in early April for Inflectra – only the second biosimilar drug approved in the United States.
US health regulators approved the drug in June, and Pfizer indicated it planned to start selling it in early October, following the required 180-day marketing notice.
Remicade, used to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, is J&J’s biggest seller. Its just-invalidated patent would have blocked so-called “biosimilars” – almost identical copies of biologic drugs – until September 2018. Pfizer hasn’t announced a price for Inflectra. Pfizer can legally begin selling Inflectra Oct. 3, though J&J will attempt to block Pfizer’s launch through its appeal.
“Janssen will continue to defend its intellectual property rights relating to its innovative medicines”, J&J said in a statement.
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The company also said that a commercial launch of an infliximab biosimilar before the outcome of the appeals would be considered “at-risk”. Biosimilar versions of Remicade are already available in certain markets outside the U.S. He has the equivalent of a buy rating on J&J and a hold on Pfizer. Today, you can download 7 Best Stocks for the Next 30 Days.
