November 24, 2024

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[THE INVESTOR] Celltrion’s biosimilar version of Janssen’s Remicade might debut in the US as early as October, as the patent suit is showing signs of coming to an end.

From Aug. 16 to 18, a U.S. District Court for the District of Massachusetts will hold a trial over the patent of Remicade, following Celltrion’s request to speed up the legal process it claims is being exploited by Janssen as a means to hindering the introduction of the biosimilar.

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South Korean biopharmaceuticals company Celltrion and Janssen Biotech have been mired in litigation over the introduction of Remsima, a biosimilar of antibody drug Infliximab, commonly known as Remicade, that treats rheumatoid arthritis and other autoimmune diseases. 

Remsima

Remsima is an affordable version of the original drug that can cost thousands of dollars for a single infusion in the US. To defend the US$7.6 billion worldwide market, as of 2012, Janssen initially filed six patent suits against the alternative, but has so far dropped four.

Remsima has been sold in Europe since 2015 under the name Inflectra, and was approved by the US Food and Drug Administration in April.

Although Janssen’s parent company Johnson & Johnson’s CEO Dominic Caruso said on an earnings call in April that a biosimilar of Remicade will not be launched in the US this year, Celltrion and its sales partner Pfizer are forecasting an earlier debut.

The US Patent & Trademark Office’s decision in February 2015 that turned down the reevaluation to maintain a US patent for Remicade only added to their confidence, and Pfizer has mentioned Oct. 3 as a possible release date.

The date is in accordance with the US regulation that states a biosimilar seller should notify the manufacturer of the reference product 180 days in advance.

By Hwang You-mee (glamazon@heraldcorp.com)