The US Food and Drug Administration (FDA) Oncologic Drug Advisory Committee (ODAC) voted 16-0 to recommend the approval of a trastuzumab biosimilar.
The indications include, but are not limited to, HER2-positive breast cancer in adjuvant and metastatic settings.
The FDA approves generic products of drugs once the agency determines that the proposed drug and brand are similar enough to be considered bioequivalent and can be used interchangeably.
The ODAC based its recommendation on data from clinical, nonclinical, and analytical studies, which demonstrated that the biosimilar trastuzumab was sufficiently similar to the reference product.
After review, ODAC confirmed that the biosimilar did not exhibit any clinically significant differences in regards to safety, potency, and purity.
- FDA oncologic drugs advisory committee unanimously recommends approval of Mylan and Biocon’s proposed biosimilar trastuzumab [news release]. Hertfordshire, England, Pittsburgh, PA, and Bengaluru, India: PRNewswire; July 13, 2017. http://www.prnewswire.com/news-releases/fda-oncologic-drugs-advisory-committee-unanimously-recommends-approval-of-mylan-and-biocons-proposed-biosimilar-trastuzumab-300488163.html. Accessed July 14 2017.