Biocon inks co-development and marketing pact with Mexican co for rh-insulin

Biotechnology major Biocon today said its wholly-owned subsidiary, Bicon SA has entered into an agreement with Laboratories PiSA SA de CV of Mexico for co-development and commercialisation of generic recombinant human insulin (rh-insulin) for the US market.

The collaboration is 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.

Biocon said it has a long standing relationship of over 10 years with PiSA, which 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.

Under the cost and profit sharing agreement, Biocon will be 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, Pisa has the advantage of 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 quality rh-insulin.

The product will be sold in the US under the Biocon brand, to address the $2 bn rhinsulin market opportunity in the US.

''Our partnership with PiSA demonstrates our commitment to provide access to affordable insulins to patients in the US. This collaboration will enable us to manufacture the rh-insulin drug product at PiSA's facilities in Mexico and commercialise it under Biocon brand in the US market, which has a huge diabetes burden with over 1.4 million people diagnosed with diabetes every year,'' Biocon chairperson and managing director Kiran Mazumdar-Shaw said.

''Applying PiSA's world class, state of the art sterile injectable and biotechnology development and manufacturing capabilities to contract manufacture Biocon's generic rh-insulin products represents a major milestone in PiSA's strategy to enter the US sterile injectable market,'' PiSA chairman and president Carlos Alvarez Bermejillo stated.

''PiSA has been marketing insulin products based on Biocon's high quality API for many years, hence this partnership to develop generic rh-insulin products represents the natural progression of a strong relationship between the two firms,'' he added.

Biocon is recognised as Asia's largest insulins producer and has been committed to provide affordable diabetes management through rh-Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for Insulin Glargine.