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# Sandoz Enbrel Biosimilar ‘Highly Similar’ to Innovator: FDA
- URL: https://www.fdaweb.com/sandoz-enbrel-biosimilar-highly-similar-to-innovator-fda/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136132

FDA reviewers are backing a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept) for treating arthritis. The agency’s Arthritis Drugs Advisory Committee is meeting 7/13 to review and vote on the submission.

“In considering the totality of the evidence submitted, the data submitted by the applicant show that GP2015 is highly similar to U.S.-licensed Enbrel, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between GP2015 and US-licensed Enbrel in terms of the safety, purity, and potency of the product,” an FDA [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510493.pdf?ref=fdaweb.com) says. “The applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that GP2015 should receive licensure for each of the indications for which U.S.-licensed Enbrel is currently licensed and for which GP2015 is seeking licensure.”