FDA Accepts Biologics License Application for Bevacizumab Biosimilar

November 21, 2019

Samsung Bioepis announced that the FDA accepted a biologics license application for SB8, a biosimilar candidate for bevacizumab.

The FDA has accepted a biologics license application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate for bevacizumab (Avastin), according to Samsung Bioepis, the developer of the agent.1

If approved, SB8 will be commercialized in the U.S. by Merck & Co., known as MSD outside the U.S. and Canada.

At the European Society for Medical Oncology Congress 2019, researchers presented findings from the multicenter, double-blind, phase III trial of the biosimilar in 763 patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).2

Patients were randomized 1:1 to receive SB8 (n = 379) or bevacizumab (n = 384) in combination with paclitaxel and carboplatin every 3 weeks, followed by either SB8 or bevacizumab as maintenance therapy. Treatment was given until disease progression, unacceptable toxicity, death, or 1 year from randomization of the last patient.

The primary endpoint was best overall response rate (ORR) by 24 weeks of chemotherapy. Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, pharmacokinetics, and immunogenicity.

Results showed that in the full analysis set, the best ORR was 47.6% and 42.8% with SB8 and reference bevacizumab, respectively, and the risk ratio was 1.11 (90% CI, 0.975-1.269). The median PFS was 8.50 months with SB8 compared with 7.90 months with reference bevacizumab, and the median OS was 14.90 months and 15.80 months, respectively. The median DOR with SB8 and bevacizumab was 5.60 months and 5.85 months, respectively.

In the per-protocol set of patients, the best ORR was 50.1% with the biosimilar and 44.8% with bevacizumab. The risk difference was 5.3% (95% CI, −2.2%-12.9%).

The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between the 2 arms, at 92.1% with SB8 and 91.1% with reference bevacizumab. TEAEs that occurred most frequently included alopecia, anemia, and nausea.

In June 2019, the FDA approved bevacizumab-bvzr (ZIRABEV™), a biosimilar to bevacizumab, for the treatment of patients with metastatic colorectal cancer; unresectable, locally, advanced, recurrent, or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent, or metastatic cervical cancer.3

References:
1. FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate [news release]. Incheon, Korea. November 19, 2019. samsungbioepis.com/en/newsroom/newsroomView.do?idx=141&currentPage=1. Accessed November 19, 2019.
2. 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.
3. Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, Zirabev™ (Bevacizumab-bvzr) [news release]. New York, NY. June 28, 2019. pfizer.com/news/press-release/press-release-detail/pfizer_receives_u_s_fda_approval_for_its_oncology_biosimilar_zirabev_bevacizumab_bvzr. Accessed November 19, 2019.