Avalere Health
An Inovalon Company

Avalere FDA expert published in Forbes Magazine

September 30, 2013

Biosimilar Innovation and its Dependence on Regulatory Framework

In her co-written Forbes Magazine piece with Dr. Scott Gottlieb, “Helping Patients Benefit From Biotech Drugs: Why Robust Biopharmaceutical Innovation Is Increasingly Dependent On Functional Regulatory Path For Quality Biosimilars,” Avalere’s Gillian Woollett, Senior Vice President, describes the history of biosimilar policy in the US, and it’s transition into a highly regulated sector: "But these opportunities – for safe, effective, and lower cost biosimilars to the existing generation of drugs, coupled with a new generation of advances to these medicines – are by no means a sure thing. The biggest challenges to these opportunities rest not with science but policy as we flout from the compact between access and innovation that the pathway was predicated upon."


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