Pfizer announced this his week that it had entered into a strategic global agreement for the worldwide commercialization with the Indian biotechnology company Biocon (Bangalore) for biosimilar versions of insulin and insulin analog products (e.g., recombinant human insulin, glargine, aspart, and lispro). The move signals Pfizer’s strategic interest in entering the biosimilars market as well as a continuing focus of building its position in emerging markets.

Under the agreement, Pfizer will make upfront payments totaling $200 million to Biocon, which is also eligible to receive additional development and regulatory milestone payments of up to $150 million and additional payments linked to Pfizer’s sales of the four Insulin biosimilar products across global markets. Pfizer will have exclusive rights to the insulin and insuling analog 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 the biosimilar Insulin products, as well as for regulatory activities to secure approval for these products in various markets. Biocon’s recombinant human insulin formulations are approved in 27 countries in developing markets, and commercialized in 23, and glargine has been launched in its first market, India, according to the Pfizer press release.

“…[T]his 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,” said David Simmons, president and general manager of Pfizer’s established products business unit, in the Pfizer press release.

Biocon is India’s largest biotechnology by revenue, according to a Pfizer press release. It is already partnered with other major drug companies in innovator-drug research. For example, Bristol-Myers Squibb (BMS, New York) partnered with the contract research organization and contract manufacturing organization Syngene (Bangalore, Karnataka, India), a Biocon subsidiary and opened a dedicated research and development facility for BMS in March 2009. Construction on the facility began in March 2007 when BMS and Biocon entered into an agreement to develop integrated drug-discovery and development capabilities at Syngene. The facility houses 360 scientists and related staff and could accommodate as many as 450 employees. The facility spans the drug-discovery and development process from initial hit to lead optimization, early pharmaceutical development, and clinical nomination, according to March 2009 Biocon press release.

Pfizer’s pact with Biocon signals Pfizer’s entry into the biosimilars market but is also consistent with the company’s strategy of partnering with domestic companies to access emerging markets. Earlier this year, Pfizer formed a collaboration with India’s Strides Arcolab (Bangalore, India) under which Pfizer will commercialize off-patent sterile injectable and oral products in the US. The finished dosage-form products will be licensed and supplied by Strides, Onco Laboratories, and Onco Therapies, two joint ventures between Strides and Aspen PharmaCare (Durban, South Africa), according to a January 2010 Pfizer press release. And in 2009, Pfizer partnered with two Indian pharmaceutical manufacturers: Aurobindo Pharma (Hyderabad, India) and Claris Lifesciences (Ahmedabad, India). Under the deal with Aurobindo, Pfizer acquired the rights to 55 solid oral-dose products and five sterile injectables in 70 emerging markets and will commercialize those products, according to a May 2009 Pfizer press release. Pfizer also acquired the rights to 15 generic injectables from Claris Lifesciences.

Pfizer is not the first pharmaceutical major to enter the biosimilars market. Merck & Co. (Whitehouse Station, NJ), for example, announced in late December 2008, the formation of Merck BioVentures, a dedicated business for developing novel biologics and follow-on biologics. Sandoz, the generics arm of Novartis (Basel Switzerland) is one of the leading biosimilars players. The company received approval for a biosimilar version of recombinant human growth hormone in 2006 in the European Union (EU) and received regulatory approval in the United States, Australia, Canada, and Japan. In 2007, Sandoz received EU approval of a glycosylated  biosimilar (recombinant human erythropoetin alfa). In 2009, it received approval for a third biosimilar in the EU, G-CSF (filgrastim).

Pfizer’s entry into the biosmilar market through its agreement with Biocon is part of partnership strategy. It will be interesting to see if the company maintains this approach as is biosimilars strategy or will develop internal assets in serving the biosimilars market.