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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.
On May 17, 2017, Janssen, a subsidiary of Johnson & Johnson (J&J), filed a lawsuit in a district court in New Jersey against Samsung Bioepis, alleging the company’s recently approved infliximab biosimilar infringes on Janssen’s patents for Remicade (infliximab). The lawsuit seeks to halt the commercial marketing of Samsung’s biosimilar Renflexis (infliximab-abda) in the United States.
Renflexis is the second FDA-approved biosimilar for Remicade and the first Samsung Bioepis product approved for marketing in the US. Samsung told Reuters it believes the lawsuit is an attempt by Janssen to impede its Remicade biosimilar’s entry into the US market.
"We are confident we do not infringe Janssen's patents," Samsung Bioepis told Reuters. "We will take all necessary measures against Janssen's attempts to violate patient rights and deny patient access to effective, lower-cost treatment options."
Remicade is a blockbuster treatment for J&J and accounted for approximately 9.7% of the company’s 2016 revenue. J&J has said that it plans to “vigorously defend” its patents for the treatment, which is the company’s highest selling US product, accounting for nearly $5 billion in sales.
Source: United States District Court of New Jersey, Reuters