Interchangeable Biosimilars – State Substitution Requirements Update

by Lauren Fuller

Question:  Are you aware of the 26 states & territories that passed substitution requirements on interchangeable biosimilars? Or how these are affected by FDA’s draft guidance entitled, Considerations for Demonstrating Interchangeability with a Reference Product?

In January 2017, the Food and Drug Administration (FDA) issued its long-awaited guidance on interchangeability of biosimilars entitled, Considerations for Demonstrating Interchangeability with a Reference Product (Guidance).  The draft guidance is awaiting comments during a 60-day public comment period.  It is unclear how the new Trump Administration’s freeze on regulations will affect the Guidance, but the comment period remains open and it continues to stand as a draft.  Advocates will continue to submit comments, yet, it is not clear whether the FDA will be authorized to address the comments and work toward finalization.  Further, questions remain about the future of the biosimilar pathway in light of Republican plans to repeal and replace the Patient Protection and Affordable Care Act (Affordable Care Act).  The Affordable Care Act was the vehicle for passage of the biosimilar law.

The primary purpose of the Guidance is to provide guidelines for sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purpose of submitting that product to the FDA for review. The FDA guidance, when finalized, will be instructive on whether pharmacists can substitute a biosimilar deemed interchangeable without a physician’s approval.  It will raise interesting questions about substitution in light of the restrictions placed on substitution by various states.

Despite the lack of any FDA-approved interchangeable biosimilars and the lack of final guidance, 26 states, including Puerto Rico, now have interchangeable biosimilar laws in place that restrict substitution.  At the end of 2016, interchangeable biosimilar bills were pending in three states:  Michigan, Ohio, and New York.  Michigan’s HB 4437 (2016) is unlikely to become law any time soon.  It has not seen any movement since it was introduced and referred to the House Health Policy Committee over a year ago.  Ohio’s HB 505 passed the House in May 2016 and was referred to the Senate Health and Human Services Committee.  The Committee has yet to consider the bill, but if they do and pass it, there is a reasonable chance it will become law.  New York’s A 8648/S 6311 (2016) bills died with the adjournment of the legislature, but could be reintroduced in the next session.

Most of the states require notice to the prescriber and the patient, although they vary in the manner of providing notice.  Most of the state laws require record keeping but range from no specific time period for retention to as high as seven years.

The remaining states have had no activity on interchangeable biosimilars legislation.  At the rate these laws are being considered and enacted, it is likely that there will be more activity in the remaining states during the next legislative sessions.  Stay tuned to SAFPhIR for breaking news on newly-enacted state and federal biosimilar laws.

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