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Biosimilars Law Blog

Tag Archives: biosimilar

Posted in Global Comparisons, News & Events

Netherlands MEB revises position on biosimilars and interchangeability

The Dutch Medicines Evaluation Board (MEB) published a new position on biosimilars, in which it accepts substitution or interchangeability of biosimilars under certain conditions. The MEB’s revised position on biosimilars was published on 31 March 2015 and replaces its previous position of 2010. The 2010 position provided that patients should be kept at the same

Posted in News & Events

SCOTUS review of the Patient Protection and Affordable Care Act and “the biosimilar thing”

While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to

Posted in News & Events

Awaiting FDA Guidance on Interchangeability for Biosimilars

The three draft Guidances recently released by the U.S. Food and Drug Administration on implementation of the Biologics Price Competition and Innovation Act of 2009 focus on how to demonstrate biosimilarity but don’t say much about demonstrating interchangeability.  FDA has asked for stakeholder input on biosimilar interchangeability at the agency’s upcoming one-day public hearing on