Guidance Missles

  • by: |
  • 03/02/2012

Two important stories from BioCentury:

FDA to hold hearing on biosimilars guidance

FDA will hold a public hearing on May 11 to discuss three recently published draft guidance documents on biosimilars. FDA said the hearing's purpose is to obtain public comment on the drafts, as well as receive input on topics to be included in the development of future biosimilar policies. The guidance documents, released early last month, indicate the agency hasn't settled some important biosimilars policy questions, including requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.

EC seeks to reduce duration of reimbursement decisions

The European Commission proposed a Transparency Directive that would reduce the time limits for member states to make pricing and reimbursement decisions for medicinal products. States would be required to issue a decision within 120 days of approval for an innovative drug and within 30 days for a generic. Current regulations require a decision for all drugs within 180 days. Member states that review the relative efficacy of a product via a health technology assessment would still be subject to the 180-day limit.

Under the proposal, member states would be required to designate an enforcement body with the power to award damages and impose penalties for delayed pricing decisions. Member states would also be required to regularly report to the EC on the time required for individual pricing decisions. The new directive is slated to begin implementation in 2014. EC said pricing and reimbursement decisions can take as long as 700 days for new drugs and up to 250 days for generics. The EC began public consultation on the proposed changes last year.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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