The collaboration is part of Biocon’s strategy to address the large demand for generic rh-insulin in the US
Biocon’s wholly owned subsidiary Biocon SA has entered into an agreement with Laboratorios PiSA S.A. de C.V (PiSA) of Mexico for the co-development and commercialisation of generic recombinant human insulin (rh-insulin) for the US market. This collaboration is a part of Biocon’s strategy to address the large demand for generic rh-insulin in the US, which accounts for over 40 per cent of the global sales of $5 billion.
This is an extension of the company’s long standing relationship of over 10 years with its trusted partner, PiSA, who has a dominant position in insulins in Mexico. Biocon’s Insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. This is a cost and profit sharing agreement with Biocon responsible for clinical development, regulatory approvals, and commercialisation of the product in the US.
This partnership will leverage Biocon’s manufacturing facilities for the drug substance and PiSA’s drug product facilities in Mexico. Furthermore, this arrangement will take advantage of Pisa’s proximity to the US market and Mexico’s NAFTA membership, which will ensure an efficient and optimal supply chain to address the needs of the US healthcare system for an affordable, high quality rh-insulin. Biocon’s global clinical development experience with Insulin Glargine for the US will be a useful precedent in developing rh-insulin for the US market. Through this collaboration, rh- insulin will be introduced under the Biocon brand to address the $2 billion market opportunity in the US.
EP News Bureau – Mumbai