Ipca Labs to license cancer, autoimmune disorder drug to US firm BSS

Drug firm Ipca Laboratories Ltd on Wednesday (September 24) announced that it has signed a definitive technology transfer and joint development agreement with BioSimilar Sciences PR LLC (BSS), USA, for a next-generation monoclonal antibody biosimilar targeting cancer and autoimmune diseases.

The agreement will transfer late-stage development, clinical manufacturing, and commercial supply of the biosimilar from Ipca to BSS' 200,000 square feet sterile campus at OcyonBio in Aguadilla, Puerto Rico. Ipca will receive milestone fees for the knowhow and technology transfer, along with royalties on net sales once the product is commercialised.

Under the terms, BSS will hold exclusive rights for the US and Canada and non-exclusive rights in certain Latin American countries. The first biosimilar launch is planned for 2027, with another molecule expected to seek FDA approval by 2028/29.

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The partnership leverages OcyonBio's sterile filling capacity of 60 million units annually, enabling production of vials, syringes, and cartridges under FDA oversight. The initiative is expected to create hundreds of high-paying biotech jobs in Puerto Rico, strengthen the US medicine supply chain, and reduce dependence on Asia and Europe.

Robert J. Salcedo, Co-Founder and CEO of BSS, said, "We are turning decades of Indian innovation into American manufacturing muscle, exactly the sort of on-shoring that boosts the economy and puts life-saving

biologies within reach of US patients. This deal leverages BSS' scientific capability while utilising OcyonBio's sterile filling capacity."

Pranay Godha, MD and CEO, Ipca Laboratories, said, "By pairing Ipca's established science with Puerto Rico's skilled workforce and BSS' regulatory expertise, we’re accelerating affordable biologies for people battling cancer and autoimmune disease worldwide."

Shares of Ipca Laboratories Ltd ended at ₹1,350.60, down by ₹43.75 or 3.14%, on the BSE today, September 24.

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