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Biosimilars Pathway Has Blind Spots As FDA And Firms Begin Roadwork

Executive Summary

Now that a pathway for approval of biosimilars has been laid out in the health care reform law, a slew of questions remain to be answered, from how FDA will implement the legislation to how the process for resolving patent disputes will play out

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On The Trail Of Biosimilar Disclosure Scofflaws: FTC To Watch For Anti-Competitive Issues

As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.

FDA Biosimilars Meeting Seeks Input On Product Naming, Foreign Data And Exclusivity

Two-day public hearing in November will cover nearly all aspects of the new pathway except the patent challenge mechanism.

FOBs: Industry Begins To Plot Course Along Pathway As It Awaits FDA Policy

Everyone in the drug industry is eagerly waiting for any sign from FDA as to how it will handle biosimilar applications. So a recent meeting with a session devoted to FDA's current position on follow-on biologics was particularly tantalizing

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