In a dramatic legal move, Johnson & Johnson (J&J) has filed a lawsuit against Samsung Bioepis, accusing the company of breaching their contract concerning a biosimilar of J&J's blockbuster autoimmune drug, Stelara. The lawsuit, filed on Monday, alleges that Samsung Bioepis entered into an unauthorized sublicense agreement with an undisclosed private label provider, prompting J&J to seek a preliminary injunction to halt the sale of the contested biosimilar.
This legal confrontation emerges amidst a flurry of activity in the biosimilar market for Stelara. Notably, J&J, in partnership with Sandoz, has recently introduced their own biosimilar, Pyzchiva, to the U.S. market. This strategic launch is part of J&J's broader efforts to maintain its market share as patents expire and competitors vie for a piece of the lucrative autoimmune treatment market.
Over the past two years, J&J has proactively negotiated settlement agreements with multiple companies, effectively delaying the U.S. entry of Stelara biosimilars. Despite these efforts, the global landscape has seen a surge in Stelara biosimilar launches, with Europe, Canada, and several other markets introducing these alternatives last year. The U.S. market is poised to follow suit, with at least six biosimilars expected to debut this year.
Adding to the competitive pressure, Teva Pharmaceuticals and Alvotech have recently launched Selarsdi, another Stelara biosimilar, in the United States. The U.S. Food and Drug Administration has designated Selarsdi as an "interchangeable" substitute, a status that will take effect after April 30, following the expiration of exclusive rights for Amgen's Wezlana.
The unfolding legal battle between J&J and Samsung Bioepis underscores the high stakes in the pharmaceutical industry as companies navigate complex agreements and competitive pressures in the rapidly evolving biosimilar market. The outcome of this lawsuit could have significant implications for future collaborations and the availability of biosimilar treatments for patients worldwide.
