Biocon and Pfizer entered into an agreement for the worldwide commercialization of Biocon’s biosimilar versions of insulin and insulin-analog products for diabetes: Recombinant Human Insulin, Glargine, Aspart, and Lispro. Under the terms of the agreement, Pfizer will make up-front payments to Biocon totaling $200 million. Biocon is also eligible to receive additional development and regulatory milestone payments of up to $150 million and will receive additional payments linked to Pfizer’s sales of these products.
Pfizer will have exclusive rights to commercialize the products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India, and Malaysia. Pfizer will also have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets.
Biocon will remain responsible for the clinical development, manufacture, and supply of these biosimilar insulin products, as well as for regulatory activities to secure approval for these products in various geographies. Biocon says its Recombinant Human Insulin formulations are approved in 27 countries in developing markets and commercialized in 23, while Glargine has been launched in its first market, India.