Revenue from the sale of biosimilars is expected to grow from $311 million in 2010 to $2–$2.5 billion in 2015, according to IMS Health in their report, The Global Use of Medicines: Outlook Through 2015 released in May 2011,. With all that revenue to be captured, it is no surprise that large pharmaceutical companies are diversifying their portfolios to accommodate this product area. When Pfizer acquired Wyeth in 2009, part of the value of that deal for Pfizer came from the acquisition of Wyeth’s development and manufacturing capabilities for biologics and vaccines, capabilities that put the company in position to enter the growing biosimilars market.
Dr. Diem Nguyen, Pfizer’s general manager for the Biosimilars Business Unit, spoke with me at last week’s BIO International convention about Pfizer’s strategy for developing biosimilars. According to Nguyen, the combination of the capabilities obtained as a result of the Wyeth acquisition with the development expertise already resident in Pfizer’s Established Products Division provides a solid foundation for Pfizer to establish leadership in the area of biosimilars. She indicated that Pfizer has established a new business unit within the Established Products Division to oversee development of proteins, monoclonal antibodies, and niche biopharmaceuticals.
Under the unit’s auspices are two important collaborations, one with Israel-based Protalix for the development of taligucerase alfa, an enzyme for the treatment of Gaucher’s disease, and a partnership with the Indian company, Biocon, to commercialize biosimilar insulin and insulin analogues. In the near term, the partnership with Biocon will focus on providing biosimilar insulin to markets in developing nations, but long terms plans are to expand to a global market. Development and manufacture of more complex products, such as antibodies or drug-antibody conjugates, will take place in the former Wyeth facilities. Nguyen said that the goals are to develop cell lines that produce products at high yields, to introduce a competitive cost structure, and provide value to stakeholders. In the end, says Nguyen, she believes that Pfizer’s goal in the production of biosimilars is to “provide quality that patients trust, value, and [give them] access to medications.”