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Biosimilars

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Biosimilars

Biosimilars

The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (ACA) on March 23, 2010. BPCIA created an abbreviated federal Food and Drug Administration (FDA) licensure pathway for products considered to be biosimilar to or interchangeable with a reference biological product.

NHF does not oppose the introduction of novel scientific development and approaches that could lead to new and more efficacious treatments that do not compromise patient safety and, therefore, is open to biosimilar products being available in the market, provided the following safety measures are in place:

  • Clinical trial data, including an assessment of immunogenicity, should be required for any biosimilar approval process
  • Approved biosimilar products should be both biosimilar and interchangeable
  • Substitution of products should not be permitted without the consent of both the patient and treating hematologist

While the FDA issued draft guidance on this issue in February 2012, final guidance has not yet been released. Some states have passed legislation regarding biosimilar product substitution or have bills currently pending. 

NHF’s position on this issue has not changed. Patients and hematologist should be involved in, and provide consent for, a pharmacist’s substitution of a biosimilar product. Furthermore, the pharmacist should provide notice to the hematologist if a substitution is made and maintain a record of the substitution.  Finally, any substituted product considered should be both biosimilar and interchangeable to ensure safety and effectiveness for the patient.

To learn more, check out Position on Legislation to Create a Regulatory Pathway for the Approval of Biosimilars. You can also learn more about the FDA guidance through the FDA’s website and resources.