Xbrane enters licensing agreement with Indian generics giant
Av Under the agreement Intas will have exclusive rights to the global commercialization of a biosimilar that Xbrane is developing, which is a version of the reference drug Opdivo (nivolumab). The commercialization will be carried out through Intas' subsidiary, Accord Healthcare.
The agreement also means that Intas will finance and be responsible for the clinical and regulatory development activities for the substance.
For this, Xbrane will receive an upfront payment of EUR 10 million from Intas, plus potential development milestone payments of an additional EUR 3 million. After the product is launched, Xbrane will be entitled to a double-digit royalty percentage of the profit generated.
Biosimilars are copies of biological drugs that can be introduced after the original drug's patent has expired, often at a lower price.
Opdivo, a therapy marketed by Bristol Myers Squibb, is approved for a range of cancer indications and had reported global sales of USD 9 billion in 2023. It is the first so-called PD1 inhibitor to lose its patent protection, which occurs in December 2028 in the USA and in June 2030 in Europe.
By then, Xbrane's biosimilar, named Xdivane, needs to be approved and ready for the market.
To obtain approval for a biosimilar, the manufacturer must demonstrate equivalence with the reference drug in terms of protein structure, impurity patterns, biological activity, efficacy, safety, and immunogenicity.
“We are convinced that Intas, given its vast capabilities in biosimilar development, is the perfect partner to finalize the development in a timely manner”, says Martin Åmark, CEO of Xbrane, in a press release.
Intas Pharmaceuticals is a multinational pharmaceutical company based in Ahmedabad, India. The company, which focuses on generic drug manufacturing, has 22 research and manufacturing facilities with a total of approximately 24,000 employees.
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