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J&J launches lawsuit to block release of Remicade biosimilar

Published on 19/05/17 at 09:33am

Samsung Bioepis gained approval to launch its biosimilar to Johnson & Johnson’s Remicade just last month, on 21 April, but faces a legal challenge from the same company. J&J is claiming patent infringement on three of the patents related to its product, as it attempts to delay the release of the biosimilar to market.

Renflexis, as Samsung’s product has been named, would be the second biosimilar to enter the US market should it navigate the legal action. Pfizer already has a biosimilar on the market, known as Inflectra, that is sapping a chunk of Remicade’s market – worth $5 billion in sales to the company per year. The drug makes up nearly 10% of J&J’s total revenue and the approval of a further biosimilar would only damage its earnings even further.

“We are confident we do not infringe Janssen's patents," Samsung Bioepis is reported to have informed Reuters in a statement “We will take all necessary measures against Janssen's attempts to violate patient rights and deny patient access to effective, lower cost treatment options.”

Samsung Bioepis is gaining a reputation as being quick at developing and bringing biosimilars to market of leading drugs. It became the first company to bring to launch a biosimilar version of Amgen’s Enbrel in Europe. It also has several biosimilars awaiting a decision in Europe in the form of copies of Roche’s Herceptin and AbbVie’s Humira.

While Samsung’s Remicade biosimilar will now have to wait to reach patients, the company already has access to market the drug in Europe and it may only be a matter of time before the same is true in the US.

Ben Hargreaves

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