J&J Loses Court Ruling on Potential Biosimilar of Remicade

Johnson & Johnson (J&J) has been issued a ruling by the District of Massachusetts Federal Court in favor of Celltrion Healthcare and Celltrion Inc. and Hospira Healthcare on a summary judgment motion filed by these companies related to patent-infringement lawsuits filed by J&J's subsidiary, Janssen Biotech, regarding the company's anti-inflammatory drug, Remicade (infliximab).

The court issued a ruling in favor of Celltrion and Hospira, holding that a patent (US Patent No. 6,284,471, i.e., the ‘471 patent) for Remicade is invalid. In a company statement, Janssen said it is “disappointed” with the court's ruling and plans to appeal the decision. Janssen is also continuing the appeal process in the proceedings related to the ‘471 patent before the US Patent & Trademark Office and is awaiting a date to be set for an oral hearing in the appeal. The ‘471 patent, granted in 2001, relates to anti-TNFa antibodies and assays employing anti-TNFa antibodies.

A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch for J&J, according to the company. The company has reaffirmed its sales guidance for operational sales growth for the full-year 2016 of 3-4%, notwithstanding the possibility of a biosimilar launch of Remicade on or after October 3, 2016. Remicade is J&J's top-selling drug with 2015 worldwide sales of $6.56 billion. Remicade in the US is indicated for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Celltrion filed a biologics license application (BLA) in the US in August 2014 for Remsima, its biosimilar of Remicade. A US Food and Drug Administration (FDA) advisory committee recommended the biosimilar for approval in February 2016. Celltrion's partner, Hospira, launched its biosimilar of Remicade, marketed under the name Inflectra, in Europe in February 2015. Inflectra was approved by the US FDA in April 2016 for multiple indications.In 2015, Pfizer acquired Hospira. 

In addition, Samsung Bioepsis, the joint venture between Samsung Biologics and Biogen, filed a BLA for its biosimilar of Remicade, now designated as SB2, to the FDA earlier this year. Also, Biogen was granted marketing authorization by the European Commission in May 2016 for Flixabi, its biosimilar referencing Remicade, in the European Union.

Source: Johnson & Johnson

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