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Bangalore-based Biocon Ltd, through its wholly owned subsidiary Biocon SA, yesterday entered into an agreement with Laboratorios PiSA SA de CV (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 percent of the global sales of $ 5 billion.
This is an extension of Biocon’s long standing relationship of over 10 years with its trusted partner, PiSA, who has a dominant position in insulin market in Mexico. Biocon’s Insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing affordable access to insulins to patients.
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, Biocon will introduce rh-insulin under the Biocon brand to address the $ 2 billion market opportunity in the US.
Kiran Mazumdar-Shaw, chairperson & managing director, Biocon, said, “This collaboration will enable us to manufacture the rh-insulin drug product at PiSA’s facilities in Mexico and commercialise 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.”
Carlos Alvarez Bermejillo, chairman & president, PiSA, stated, “Applying PiSA’s world class, state of the art sterile injectable and biotechnology development & 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 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.”
