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Round Table Discussion on the
Role of Quality Manufacturing in Realizing the Potential of Biosimilars
August 11, 2014
ROUND TABLE SUMMARY
On August 11, 2014, experts from academia, public policy, and the private sector met at Columbia University to explore manufacturing best practices in the development of biosimilars, highly similar versions of approved and authorized biological medicines (biologics). Pfizer launched its new paper Biosimilars: Manufacturing Critical, and participants discussed the potential of these innovative medicines to advance healthcare.
The round table, hosted by the Deming Center at Columbia Business School and Pfizer Inc, addressed key differentiating factors of biosimilars from innovator drugs as well as traditional generics. A key takeaway that emerged was that the role of quality manufacturing is critical in ensuring highest quality biosimilars, particularly as clinical-scale (small batch) biosimilars are often very different from commercial-scale (large batch) biosimilars. Despite significant regulatory and branding challenges ahead before biosimilars come to market in the United States, participants agreed that biosimilars represent new innovation and the potential to provide a broader range of life-saving medicines to treat a number of life-threatening and chronic conditions.