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FDA Announces Biosimilar Innovation Plan


On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.

On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.

In its 2018 Strategic Policy Roadmap, the agency said that it will launch a Biosimilar Innovation Plan this year. As part of the overall effort, the FDA reports that its plan will “create better incentives” for the adoption of biosimilars as a way to spur greater competition among and reduce the costs of biologic therapies. “Greater access to effective drugs also helps advance the public health and lower overall healthcare costs by improving health outcomes and reducing the cost and burden of disease,” said the FDA’s Roadmap, adding that enabling access to innovative drugs is a critical aspect of the agency’s mandate.

The agency is also taking steps to facilitate greater generic drug competition as part of its existing Drug Competition Action Plan, and says that it will, among other steps:

  • Issue new draft guidance in the first quarter of 2018 on the FDA’s process for determining whether to waive the requirement for generic firms to adopt a single, shared-system risk evaluation and mitigation strategie (REMS) program with branded drug makers
  • Issue new guidance concerning the agency’s approach to citizen petitions to the FDA
  • Address regulatory policy obstacles to the entry of complex generics
  • Improve the efficiency of the agency’s generic review program
  • Implement a pre-abbreviated new drug application (ANDA) program
  • Promote the efficient market entry of drug-device combinations
  • Develop guidance to modernize the administration of Hatch-Waxman

The agency also announced that it will issue final guidance on product developers’ communications with payers about the economic consequences of their products (which may promote value-based contracting), and will establish an inter-agency working group to explore areas where the FDA can collaborate with the Federal Trade Commission on issues related to competition.

In a statement, FDA Commissioner Scott Gottlieb, MD, said, “In focusing on these selected efforts, we will optimize our resources to achieve clear deliverables that will yield results over the next [2] years.” He added, “Publishing this Roadmap is another way that we aim to provide more transparency about the FDA’s policy undertakings to all our stakeholders.”

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