Legal Challenges Begin for Biosimilar Agents

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As key biologics near the end of their patent-protection periods, industry is preparing for legal battles over biosimilar versions.
As key biologics near the end of their patent-protection periods, industry is preparing for legal battles over biosimilar versions.

Legal challenges have begun in the U.S. for biosimilar versions of biologic agents, and there will likely emerge considerable variation between states regarding pharmacy substitution laws for biosimilar agents. But ultimately, the expiration of biologics patents will hasten development of new and better anticancer agents, an expert tells Cancer Therapy Advisor.

Biologics are key players in cancer therapy and supportive care. As key biologics near the end of their patent-protection periods, industry is preparing for protracted legal battles over biosimilar versions of biologics like trastuzumab (Herceptin; Genentech/Roche).

Unlike generic drugs, “biosimilars” mimic larger, more chemically complex and biologically derived molecules. Under the U.S. Biologics Price Competition and Innovation Act of 2009 (BPCIA), biosimilars must be empirically demonstrated to be statistically “highly similar” to a U.S. Food and Drug Administration (FDA)-approved reference biologic despite minor differences “in clinically inactive components.”1

Biosimilarity means there can exist no “clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency.” 1

The law also defines an even stricter standard for biologics “interchangeability” that require the same clinical result as seen with a branded reference biologic agent be empirically established for the biosimilar agent; interchangeable biosimilars must be empirically shown to involve no diminished safety or efficacy from “alternating or switching” between it and a reference agent, compared to continued use of the approved reference.1

Long-anticipated legal challenges have now begun: In October, Amgen filed suit against Sandoz in federal court alleging patent infringement and unfair competition and conversion, regarding Sandoz's application for FDA approval of Zarzio, its biosimilar version of Amgen's filgrastim (Neupogen).2

Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog biologic indicated for leukopenia in patients with cancer. Amgen alleges that Sandoz has refused to provide manufacturing information within the time limit imposed by the BPCIA, and has filed a citizen petition to the FDA urging the agency to require that biosimilar applicants certify that they will comply with regulatory time limits and other provisions of the Act before FDA accepts applications for review.

RELATED: An Overview of Biologics and Biosimilars

These moves “have undeniable ramifications for the future of commercial development, only exacerbating the inherent uncertainty in the biosimilar pathway to market,” notes Jordan Paradise, the Schering-Plough Professor of Law in Health Care Regulation and Enforcement at Seton Hall University School of Law in Newark, NJ.2

They are also only the first of many complex legal maneuvers to come regarding biosimilars, say experts like Kevin M. Nelson, a pharmaceutical patent attorney with Duane Morris LLP in Chicago, IL.3

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