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IPQ Inside the global regulatory dialogue

Understanding Biosimilar/Biobetter Approval Pathways and Differences Key to Success, Merck Exec Says

Jul 30th, 2010

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Success for both biotech innovator companies and biosimilar manufacturers under the new health care legislation will require working with FDA to optimize the regulatory approval pathways and understanding the key differences between biosimilars and biobetters, a Merck executive maintained in a recent interview.

Merck Bioventures President and Biologics/Vaccines Senior VP Michael Kamarck commented in a BioPharm International podcast in early July that the new health care legislation “really hits the sweet spot” both for companies that are developing innovative products and for those producing biosimilars.

Benefiting innovator companies in the legislation is a 12-year exclusivity period.  For biosimilar manufacturers, Kamarck pointed out, there are clinical pathways that are somewhat abbreviated and that would allow a reduction in the time and some of the costs as compared to the requirements for an innovator product.

Every company will develop its own strategy for filing “based on what it feels the risks are,” commented the Merck VP – some may choose abbreviated pathways for biosimilars, while others may choose to file traditional biologic license applications (BLAs).

The earlier users of the regulatory pathway, including Merck, will have the opportunity to work with FDA to optimize the pathway and make it efficient.  “In doing that, I think we will make the pathway hugely valuable” in the future, Kamarck commented.

[More from Kamarck on biosimilar and biobetter opportunities and challenges is available to subscribers on page 2.]

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