Biocon Signs Rh-insulin Co-development Agreement With Mexican Co

Kiran Mazumdar-led Biocon has on Thursday (17 March) signed a generic recombinant human insulin (rh-insulin) development and marketing agreement with Mexico's Laboratorios PiSA SA 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.

It also marks an extension of Biocon's 10-years long relationship with the Mexican company, which is a dominant player in insulins in that market. Biocon's Insulin Glargine was the first to be approved in Mexico in 2015. with the ne partnership, both companies are committed to providing affordable access to insulins to patients. This is a cost and profit sharing agreement in which Biocon will be responsible for clinical development, regulatory approvals, and commercialization of the product in the US.

This partnership will leverage Biocon’s manufacturing facilities for the drug substance and Laboratorios' drug product facilities in Mexico. In addition, 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 the new product.

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, the Indian company we will introduce rh- insulin under the Biocon brand to address the $2 billion market opportunity in the US.

“Our partnership with PiSA demonstrates our commitment to provide access to affordable insulins to patients in the US," said

Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw.

This collaboration will enable us to manufacture the rh-insulin drug product at PiSA’s facilities in Mexico and commercialize it under Brand Biocon in the US market, which has a huge diabetes burden with over 1.4 million people diagnosed with diabetes every year, she added.

Biocon is currently one of the large insulins producers in Asia and it has a range of products including rh-Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. It also has marketing approvals in at least 60 countries for rh-Insulin and in some 20 countries for Insulin Glargine.