IPCA Labs has signed a definitive technology transfer and joint development agreement with BioSimilar Sciences PR LLC (BSS), USA. The collaboration is for a next-generation monoclonal antibody biosimilar aimed at treating cancer and autoimmune diseases.
A monoclonal antibody biosimilar is a near-copy of an original antibody drug, designed to treat diseases like cancer and autoimmune conditions affordably.
What’s happening: under the agreement, IPCA will hand over late-stage development, clinical manufacturing, and commercial supply of the biosimilar to BSS. These activities will take place at BSS’s 200,000-square-foot sterile facility on the OcyonBio campus in Aguadilla, Puerto Rico.
IPCA will earn milestone payments for sharing its technology and will also get royalties from product sales once it hits the market. BSS will also 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 202829.
Why it matters: the partnership uses OcyonBio’s facility, which can produce 60 million vials, syringes, and cartridges each year under FDA supervision. It is expected to create hundreds of high-paying biotech jobs in Puerto Rico, boost the US medicine supply chain, and cut reliance on Asia and Europe.