Market Strengths and Weaknesses in Biosimilars - Pharmaceutical Technology

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Market Strengths and Weaknesses in Biosimilars
An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars. This article is part of a special issue on outsourcing.


Pharmaceutical Technology
Volume 36, Issue 8, pp. s34-s38, s60

A biosimilars parting of the ways

Not all biosimilar partnerships have succeeded. In March 2012, Pfizer and the Indian biotechnology company Biocon ended their alliance to commercialize Biocon's biosimilar versions of insulin and insulin analog products. The companies agreed that due to the individual priorities for their respective biosimilars businesses, it was in their best interest to move forward independently. Pfizer and Biocon had signed their biosimilar pact in October 2010 for the worldwide commercialization of Biocon's biosimilar versions of insulin and insulin analog products: recombinant human insulin, glargine, aspart, and lispro. Under the 2010 agreement, Pfizer had 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 also had have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets. Under the 2010 agreement, Pfizer made upfront payments totaling $200 million, and Biocon was eligible to receive additional development and regulatory milestone payments of up to $150 million and to receive additional payments linked to Pfizer's sales of its four insulin biosimilar products across global markets.

References

1. IMS Health, Shaping the Biosimilars Opportunity: A Global Perspective on the Evolving Biosimilars Landscape (Jan. 2012).

2. FDA, Draft Guidance for Industry on Biosimilars: Q&As Regarding Implementation of the BPCI Act of 2009 (Rockville, MD, Feb. 2012).

3. FDA, Draft Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Feb. 2012).

4. FDA, Draft Guidance for Industry Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Rockville, MD, Feb. 2012).

5. R. Haustein et al., Saving Money in the European Healthcare Systems with Biosimilars IGES Institute (Berlin, Dec. 2011).


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