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- 07/26/2017

Johnson & Johnson’s Remicade faces new competion from a biosomilar launched in the US market

Pharma Horizon

Samsung Bioepis has announced that has begun selling a cheaper biosimilar drug referencing Johnson & Johnson’s Remicade in the US via its partner Merck & Co., marking the second Remicade copy to hit the US market. 

Samsung’s Remicade biosimilar will be introduced in the US at a wholesale acquisition price of $753.39, which is 35 percent cheaper than the current listing price of Remicade, according to the two drugmakers.

“Since we were established five years ago, we have striven to bring high-quality treatment options at a lower cost to US patients. Renflexis is our first step in meeting this important commitment,” Samsung Bioepis President and CEO Ko Han-sung said in a statement. “We firmly believe biosimilars will play an instrumental role in making health care more accessible to patients across the US, and we will continue our relentless drive to advance one of the industry’s strongest pipelines.”

J&J-owned Janssen, the developer of Remicade, has filed a lawsuit against Samsung Bioepis in the US, claiming that its biosimilar copy Renflexis infringes three of its patents related to Remicade’s manufacturing process. A hearing has yet to be scheduled.

Samsung Bioepis has stated that Janssen’s moves were expected and that it did not infringe on Janssen’s patents.

Renflexis is the second biosimilar referencing Remicade to be commercialized in the US, following Celltrion’s Inflectra, which hit the US market via Pfizer from November 2016. 

Samsung Bioepis already sells multiple biosimilars in global markets in addition to Renflexis, which has won approval in Europe, Australia and Korea. Its Enbrel biosimilar was the first of its kind to hit Australia, Canada, Korea and Europe.

Its biosimilar copy of Humira, Imraldi, was recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June. Its Herceptin biosimilar is currently under review by the EMA. 

Founded in 2012, Samsung Bioepis is a joint venture between Samsung BioLogics and US-based Biogen with the former holding a 91.2 percent stake. 


Source: Korea Herald

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