The FDA Will Review Samsung Bioepis' Proposed Bevacizumab Biosimilar, SB8

November 19, 2019

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

If approved, the biosimilar will be marketed in the United States by Merck, which has also been the company’s partner on its biosimilar infliximab, Renflexis.

The biosimilar was also recently accepted for review by the European Medicines Agency, where it awaits an opinion from the Committee for Medicinal Products for Human Use.

During September’s European Society for Medical Oncology Congress 2019, researchers presented findings from the phase 3 trial of the biosimilar in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

In the study, 379 patients were randomized to receive the proposed biosimilar together with paclitaxel and carboplatin every 3 weeks, and 384 were randomized to receive the reference bevacizumab with the same chemotherapy regimen. Treatment was followed by biosimilar or reference bevacizumab maintenance therapy until disease progression, unacceptable toxicity, death, or 1 year from randomization of the last patient.

The study’s primary end point was the best overall response rate (ORR) by week 24. In the full analysis set, the best ORR was 47.6% in the biosimilar arm versus 42.8% in the reference arm. The risk ratio was 1.11 (95% CI, 0.975-1.269), which fell within the prespecified equivalence margin of 0.737-1.357.

In the per-protocol set, the best ORR was 50.1% in the biosimilar arm and 44.8% in the reference arm. The risk difference was 5.3% (95% CI, −2.2% to 12.9%); the lower margin was contained within the prespecified equivalence margin of −12.5% to 12.5%, though the upper margin fell outside of this margin.

Pharmacokinetic parameters, as well as the incidence of antidrug antibodies, were comparable in the 2 treatment arms.

If the biosimilar gains approval in the United States, it will join the ranks of Amgen’s Mvasi, which has already launched in the US market, and Pfizer’s Zirabev, which will be launched on December 31, 2019.

Reference

Reck M, et al. A phase III study comparing SB8, a proposed bevacizumab biosimilar, and reference bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Presented at: European Society for Medical Oncology Congress 2019; September 27 to October 1, 2019; Barcelona, Spain. Abstract 1565P.


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