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
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.