Biocon, and Pfizer Inc. have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of insulin and insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro.

Under the pact, Pfizer will have exclusive rights to commercialize these 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. The company’s 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.

Under the terms of the agreement, Pfizer will make upfront payments totalling $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 its four Insulin biosimilar products across global markets.

Commenting on this major alliance, Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said: "This is indeed a significant inflection point in our globalization path. Pfizer and Biocon bring together a winning combination of marketing, manufacturing and research excellence which can build a formidable global footprint in diabetes care. Pfizer brings brand strength and a vast and unrivalled global marketing network that will enable Biocon to realize its objective of seeing its Insulin portfolio have a worldwide presence."

"We are excited to join forces with Biocon in the battle against the disease and economic burden that Diabetes poses to global health. Our alliance with Biocon will enable the delivery of biosimilar Insulin products, providing attractive, cost-effective treatment options to more Diabetes patients," said David Simmons, president and general manager of Pfizer's Established Products Business Unit.

"In addition, this collaboration supports our stated efforts to become a strong player in follow-on biologics as well as in the diabetes disease area, by adding to Pfizer's broad biotherapeutics portfolio, ranging from biosuperiors to biosimilars, across multiple therapeutic areas, which we've said we will supplement with both our in-house development efforts and selective collaborations”, he added.

The 2010 market for diabetes drugs and devices is estimated at $40 billion with Insulins accounting for $14 billion or 35 per cent of the diabetes  segment. By 2015, a number of Insulin analogs are expected to lose patent protection, resulting in a significant opportunity for the biosimilars market. With this alliance, Pfizer and Biocon expect to be well positioned to be first movers in this potentially large market opportunity.

Diabetes is one of the fastest-growing and largest disease burdens globally, with nearly 230 million diabetic patients worldwide and 3 million deaths attributed to the disease annually. Although Insulin is the primary response to address diabetes and is included on The World Health Organization's (WHO) Essential Medicines List, it remains inaccessible on an uninterrupted basis in many parts of the developing world.