The Nivolumab biosimilar will be commercialized by Intas, through its subsidiary Accord Healthcare, which plays a significant role in the global biosimilar market. With a strong focus on oncology, Accord has extensive commercial expertise and currently supplies about one-third of injectable oncology medicines in Europe, states Xbrane.

We believe that introducing biosimilars for core oncology treatments, particularly PD-1 inhibitors, plays a critical role in advancing cancer care.

“We are now, with this partnership, very well positioned to bring our Nivolumab biosimilar candidate to launch at the time of patent expiration of Opdivo in the US in December 2028 and June 2030 in Europe and generate significant income from profit sharing from that point and onwards. Opdivo will be the first PD1 inhibitor to go off patent and has reported global sales of USD 9 billion in 2023 with 9% growth. We are convinced that Intas, given its vast capabilities in biosimilar development, is the perfect partner to finalize the development in a timely manner. We are also convinced that Intas’ commercialization arm Accord, given its previous achievements and track record with oncology biosimilars such as Pelgraz, Accofil and Zercepac will do a phenomenal job in commercializing our Nivolumab biosimilar in global markets. We believe that introducing biosimilars for core oncology treatments, particularly PD-1 inhibitors, plays a critical role in advancing cancer care. By making these foundational therapies more accessible, biosimilars enable healthcare systems to allocate more resources towards innovative combination treatments, which have the potential to improve overall treatment outcomes,” says Martin Åmark, CEO of Xbrane.

An upfront payment of EUR 10 million

Under the exclusive agreement, Intas will finance and oversee the clinical and regulatory development activities, as well as the global commercialization of the Nivolumab biosimilar candidate. As part of the agreement, Xbrane will receive an upfront payment of EUR 10 million from Intas, in addition to development milestone payments of EUR 3 million. After the product is launched, Xbrane will also be entitled to receive double-digit royalties on profits.