First Biosimilar Recommended for Approval by FDA

On January 7, industry stakeholders lauded as historic a U.S. Food and Drug Administration (FDA) advisory committee’s recommendation to approve the first biosimilar application in the U.S. The FDA defines a biosimilar as a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.1 Sandoz, a Novartis company, had submitted the application to the FDA for approval of its biosimilar to Amgen’s Neupogen® (filgrastim).2

The FDA’s Oncologic Drugs Advisory Committee (OADC) considered the clinical evidence presented by Sandoz during the January 7 public meeting and found that there were no meaningful clinical differences between Sandoz’s filgrastim and the originator product.3 While the advisory committee’s recommendations are not dispositive, the FDA does often follow the findings of its advisory committees and is expected to make a decision regarding Sandoz’s filgrastim biosimilar application this spring.

The FDA advisory committee’s recommendation was significant amid ongoing debate among healthcare policymakers and in state legislatures in regard to the naming, labeling, interchangeability, and notice requirements for biosimilars. Stakeholders have been at odds over how biosimilars should be named for purposes of distinguishing them from originator products, and whether healthcare providers should be put on notice when a follow-on biologic is substituted for an originator product. While stakeholders commented on some of these issues at the January 7 meeting—such as how Sandoz’s biosimilar should be named should it garner FDA approval—the OADC did not offer a specific direction on these topics.4

Of note, from 2013 – 2014, at least 23 states have considered legislation on biosimilars.5 These bills have generally considered questions of prescriber and patient notice and substitution. Some of these bills have also raised speculation about potential competition issues, as examined by the Federal Trade Commission at a February 2014 workshop on follow-on biologics.6

Interestingly, at the January 7 meeting, the OADC approved all five indications for which Sandoz had applied and Amgen’s Neupogen® is approved. Sandoz had provided clinical trial evidence for only one of the indications, but the FDA approved the other four by extrapolation, as permitted by section 351(k) of the Public Health Service Act.7 Some industry stakeholders believe that the FDA’s use of extrapolation could increase consumer access to biosimilars by decreasing research costs for manufacturers.8

Meanwhile, there is ongoing litigation and a citizen’s petition pending at the FDA in regard to what information should be shared between companies who apply for biosimilar approval and originator companies.9 The FDA’s treatment of biosimilars and legislative efforts to shape biosimilar prescribing will remain hot topics. Healthcare stakeholders should stay abreast of developments in this area.

  1. 42 U.S.C. § 262(i)(2)); See U.S. Food and Drug Administration (“FDA”), drugs approvals and databases. Drugs@FDA glossary of terms. Available here.
  2. See Sandoz press release, Althoff, Eric, et al., “Sandoz Biosimilar Filgrastim Recommended for Approval by FDA Oncologic Drugs Advisory Committee” January 7, 2014. Available here.
  3. See FDA, “FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, January 7, 2015, BLA 125553 EP2006, a proposed biosimilar to Neupogen® (filgrastim) Sandoz Inc., a Novartis company” pg. 9. Available here.
  4. See Wilson, Todd Allen, “FDA Advisers Recommend Approval Of First U.S. Biosimilar Application” Inside Health Policy, January 7, 2015. Available here.
  5. See Cauchi, Richard, “State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars.” National Conference of State Legislatures, January 7, 2015. Available here.
  6. See Federal Trade Commission (“FTC”), Public Workshop: Follow-On Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition; Notice of December 10, 2013 Workshop to Explore Competition Issues Involving Biologic Medicines and Follow-On Biologics; Request for Comment . 78 FR 68840. Available here.
  7. In this circumstance, the FDA extrapolated its findings based on the clinical evidence for one indication to other indications. See P.L. 78-410.
  8. Mueller, Lisa L., “Inching Close to the First Biosimilar Approval in the U.S.” National Law Review, January 12, 2015. Available here.
  9. See Silverman, Ed, “Amgen and Sandoz Square off Over a Biosimilar Application” Wall Street Journal, November 3, 2014. Available here.

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