In This Issue:

- Stakeholders Urge FDA to Provide Clarity on Biosimilars

- Ebola Crisis Continues

- Implementation of the Affordable Care Act

- Other Federal Regulatory Initiatives

- Other Congressional and State Initiatives

- Other Health Care News

- Upcoming Congressional Hearings and Markups

- Excerpt from Stakeholders Urge FDA to Provide Clarity on Biosimilars:

Following the publication of Food and Drug Administration (FDA) draft guidance in May 2014, industry groups, including BIO, PhRMA, and some of their member companies, are concerned with the guidance. The draft is intended to help companies that design and utilize clinical pharmacology studies demonstrate the similarity between a biosimilar and its reference product. BIO and PhRMA are worried that the FDA’s four categories for comparing biosimilars to their reference products do not provide enough clarity and will ultimately result in safety issues with biosimilar medicines. The four tiers designated by FDA are: 1) not similar; 2) similar; 3) highly similar, and 4) highly similar with “finger-print like” similarity. Specifically, stakeholders are asking the agency to eliminate eventual ambiguity and provide additional guidance to differentiate between the tiers, such as the difference between “similar” and “highly similar.” Although it is likely that FDA will provide additional clarity between the four tiers, experts believe that the agency is likely to leave a significant amount of ambiguity that gives regulators flexibility moving forward.

Please see full issue below for more information.

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FDA

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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