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A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States.

Interestingly, generics of traditional drugs have been available in the U.S. for decades as a less expensive alternative to brand-name drugs and biosimilars have been available in Europe for several years. But in the U.S., the pathway to approval of biosimilars is relatively new. The Biologics Price Competition and Innovation (BPCI) Act, passed as part of the ACA, created an approval pathway for biologics that can be demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic drug. In addition to creating a means for approval of lower-cost biosimilars, the BPCI Act also granted original biologic drugs exclusivity for 12 years.

The FDA’s <a href="http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/">Oncologic Drugs Advisory Committee</a> recently recommended that the FDA approve Novartis’s Zarxio, a drug that the <a href="http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM428780.pdf" target="_blank" rel="noopener">Committee determined</a> has “no clinically meaningful differences” from Amgen’s Neupogen. Neupogen boosts white blood cells in cancer patients.

The FDA is not obligated to follow the Committee’s recommendation, but it will likely carry significant weight as the FDA often agrees with these kinds of recommendations. If ultimately approved by the FDA, Zarxio would be the first biosimilar authorized for marketing in the U.S.

The Committee’s recommendation for Zarxio’s approval is notable not only because it would represent the first biosimilar available in the U.S., but the Committee’s review and analysis of Zarxio’s application also may provide valuable guidance for other manufacturers seeking approval for biosimilars. At least one other drug manufacturer has filed an application seeking FDA approval for a biosimilar. But the FDA has not yet finalized guidance on issues including <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf" target="_blank" rel="noopener">quality considerations in demonstrating biosimilarity to a reference protein product</a> and the <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf" target="_blank" rel="noopener">clinical pharmacology data needed to demonstrate biosimilarity</a>, though it has <a href="http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm">stated</a> that it will “require licensed biosimilar and interchangeable biological products to meet the Agency’s exacting standards of safety and efficacy.” The FDA also recently <a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf" target="_blank" rel="noopener">announced</a> that it plans to issue four guidance documents in 2015 addressing biosimilars.

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs