Drugs

Comments on FDA Insulin Biosimilar Docket

David McFarland

— 2 min read
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The Association for Accessible Medicines and its Biosimilars Council say they support FDA efforts to foster biosimilar competition in the interest of building a sustainable marketplace for those innovative medicines. Following an FDA 5/13 hearing on the future of insulin biosimilars, the association and council recommend that: 

  •          FDA has significant experience with insulin and a “highly similar” regulatory standard and should apply that experience to biosimilar insulin development;
  •          FDA should continue to highlight for stakeholders that interchangeability does not confer quality, but is a statutory standard for automatic substitution at the pharmacy; and
  •          FDA should continue emphasizing that a transition from a reference product to a non-interchangeable biosimilar will not result in changes to safety or effectiveness.

In its comment, Lilly says that in the short term, FDA should focus its efforts on developing biosimilarity and interchangeability standards for current standard of care insulin presentations such as standalone pens and pumps. “With an evolution of diabetes care in sight,” the company adds, “Lilly believes that FDA also must develop biosimilarity and interchangeability standards for insulin products in connected diabetes systems. We recommend that FDA consider biosimilarity and interchangeability of connected diabetes systems separately from standard of care presentations and based on careful evaluation of the complex issues raised by these systems.”

Mylan says it believes that sufficient tools exist to evaluate presentations and delivery devices, whether the reference product is approved as a combination product or is administered via separately cleared standalone medical devices. The company also reiterates its wish that FDA reverse its policies regarding the transition process and non-proprietary naming of biosimilars and interchangeable biologics.

The Biotechnology Innovation Organization (BIO) says it has been and continues to be a strong supporter of agency efforts to advance implementation of the Biologics Price Competition and Innovation Act (BPCIA). It notes that biosimilars and interchangeable biosimilars are “highly similar” but not identical to their reference products in terms of active substance. It also points out that biologics are inherently more complex than small molecule therapeutics and thus require policies distinct from those for generic small molecule drugs. Since insulin is a protein and biologic, BIO says, FDA should apply the same principles it is applying to other biosimilar development programs as outlined in its published guidances that implement the BPCIA.

JDRF (formerly the Juvenile Diabetes Research Foundation) says FDA should adopt policies that will encourage biosimilar development to increase competition in the insulin market while also fostering innovation to improve the care for people with diabetes.

Finally, the United States Pharmacopeia (USP) says regulatory changes required by the BPCIA must be implemented in a manner that is clear, transparent, and minimally disruptive to patients. It says USP standards should be applicable to the quality of both drug and biological products, regardless of regulatory pathway.

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