Biosimilars Pathway Has Blind Spots As FDA And Firms Begin Roadwork
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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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.
Two-day public hearing in November will cover nearly all aspects of the new pathway except the patent challenge mechanism.
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