HHS Seeks Comments From Biosimilars Stakeholders

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This comment period is important for biosimilar stakeholders because the Trump administration's plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

In his speech last Friday, President Trump unveiled his blueprint for reducing the price of drugs for American patients. In a notice published today on the Federal Register, HHS has announced that it is seeking comment on the blueprint to help shape future policy development and agency action. This comment period is important for biosimilar stakeholders because the plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

Through the plan, the FDA is prioritizing efforts to improve the efficiency of the biosimilar and interchangeable product development and approval process by working to identify areas where additional information or development tools may facilitate increased growth of biosimilars. Specifically, the agency has asked industry what types of resources or tools they would find most effective in reducing development costs.

Additionally, HHS is calling on the FDA to improve the Purple Book, where the FDA publishes information about licensed biological products. HHS is requesting opinions about how the Purple Book could be more useful to healthcare professionals, patients, manufacturers, or other stakeholders.

In order to improve the education of providers and patients about biosimilars, the FDA intends to continue to build on the momentum of prior education efforts. Previous actions included the launch of its Biosimilars Education and Outreach campaign in 2017, as well as graphics, fact sheets, and other resources available on its website.

In addition, FDA Commissioner Scott Gottlieb, MD, has also recently hinted that the FDA could publish the names of pharmaceutical companies that have been accused of withholding drug samples from generic or biosimilar developers.

Finally, HHS and the FDA have also recognized that thus far, no drug manufacturer has applied for or developed a biosimilar with the intention of seeking an “interchangeable” designation. To address this, HHS is requesting comment about how the designation could be improved, and what effects would the change have on the prescribing, dispensing, and coverage of biosimilar and interchangeable products. The FDA has not yet issued final guidance on demonstrating interchangeability of a biosimilar with its reference, though draft guidance has been released.

Stakeholders and interested parties may submit comments from today until July 16, 2018.

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