Momenta Pharmaceuticals, Inc. (MNTA)

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MEDIA ADVISORY

Momenta Applauds FDA Denial of Citizen Petition Requesting FDA Mandate of Information Sharing in Biosimilars Review Process

- FDA Reaffirms Separation of Biosimilar Application Process from Biosimilar Patent Exchange Process -

Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) today applauded the Food and Drug Administration (FDA) for its denial of Amgen’s Citizen Petition asking the FDA to play a role in the patent exchange process. Amgen sought to require the FDA to force applicants to certify delivery of their application to their reference product competitor.

“We are very pleased that the FDA considered Momenta’s comments in recognizing its authority under the Biologics Price Competition and Innovation Act (BPCIA),” said Craig Wheeler, President and Chief Executive Officer of Momenta. “We believe the FDA’s denial of this petition is a step in the right direction toward encouraging the use of the 351(k) pathway and promoting an efficient review and approval process for biosimilars.”

A copy of Momenta’s comment letter is available at http://1.usa.gov/1CSiLKw. The FDA’s
Citizen Petition Denial Response is available at http://1.usa.gov/1FNqjQM.