Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices. The HHS blueprint to lower drug prices includes improving competition by promoting innovation and competition for biologics. According to HHS, “FDA will issue new policies to improve availability, competitiveness, and adoption of biosimilars as affordable alternative to brand biologics. FDA will also continue to educate clinicians, patients, and payors about biosimilar and interchangeable products as we seek to increase awareness about these important new treatments.”
HHS is interested in public comments about how the department can take action to improve competition, including to address several policy questions relating to biosimilars:
“Like some generic drug developers, companies engaged in biosimilar and interchangeable product development may encounter difficulties obtaining sufficient samples of the reference product for testing. What actions should be considered to facilitate access to reference product samples by these companies?”
“What specific types of information resources or development tools would be most effective in reducing the development costs for biosimilar and interchangeable products?”
“How could the Purple Book be more useful to health care professionals, patients, manufacturers, and other stakeholders? What additional information could be added to increase the utility of the Purple Book?”
“What types of information and educational resources on biosimilar and interchangeable products would be most useful to health care professionals and patients to promote understanding of these products? What role could state pharmacy practice acts play in advancing the utilization of biosimilar products?”
“How could the interchangeability of biosimilars be improved, and what effects would it have on the prescribing, dispensing, and coverage of biosimilar and interchangeable products?”
Comments must be submitted by July 16, 2018.