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February 7, 2017, 12:00 PM

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Couldn't make it to the event? Check out some of the speakers' slides below!

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product.

This panel of experts discussed the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics included how the next generation of biosimilars could improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event was free and open to the public.

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Slide Presentations

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Eagle Biologics.


Videos

VIDEO: Welcome Remarks, Holly Fernandez Lynch and Aaron S. Kesselheim

VIDEO: Jennifer DiGiacinto, "Biosimilars & BioBetters - The Differences Between Both and the Two Very Different FDA Regulatory Pathways"

VIDEO: Robert S. Langer, "Biologics present unique delivery challenges"

VIDEO: Benjamin Roin, "Intellectual Property and Innovation Policy"

VIDEO: Audience Q&A

Tags

biotechnology   fda   genetics   health law policy   innovation   intellectual property   pharmaceuticals   regulation