Bevacizumab Biosimilar Approved for Intravenous Use in Solid Tumors

Pharmacokinetic, efficacy, safety, and immunogenicity data showed that bevacizumab-nwgd was comparable to bevacizumab in various cancers.

The FDA approved bevacizumab-nwgd (Jobvene), a biosimilar to bevacizumab (Avastin), for intravenous use in various cancer types, according to a press release with the developer, Biocon Biologics.¹

The approval came after the submission of a package of pharmacokinetic, efficacy, safety, nonclinical, structural, analytical, and functional data that showed bevacizumab-nwgd is similar to bevacizumab. In terms of pharmacokinetics, efficacy, safety, and immunogenicity, no clinically meaningful differences were observed between bevacizumab-nwgd and bevacizumab.

The agent is currently approved in the following indications:

• Colorectal Cancer
  • Metastatic colorectal cancer (CRC) with intravenous fluorouracil-based chemotherapy in first- or second-line settings.
  • Metastatic CRC with fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin-based chemotherapy in the second-line treatment of patients who progressed on first-line therapy including bevacizumab.
  • The press release noted that bevacizumab-nwgdis not approved in the use of adjuvant colon cancer
• Unresectable, locally advanced, recurrent, or metastatic non-squamous non–small cell lung cancer (NSCLC) with carboplatin and paclitaxel.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma with interferon α.
• Gynecologic Cancer
  • Persistent, recurrent, or metastatic advanced cervical cancer with paclitaxel and cisplatin or paclitaxel and topotecan.
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer
    • Carboplatin and cisplatin followed by bevacizumab-nwgd in stage III or IV disease after initial surgical resection;
    • In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan in platinum-resistant recurrent disease with 2 or less prior chemotherapy regimens;
    • In combination with carboplatin and paclitaxel or carboplatin and gemcitabine followed by bevacizumab-nwgd in platinum-sensitive recurrent disease.

“The US FDA approval of [bevacizumab-nwgd] is a significant milestone—our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio,” said Shreehas Tambe, chief executive officer and managing director at Biocon Biologics Ltd. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.”

Potential safety concerns with bevacizumab-nwgd include gastrointestinal perforations and fistula, surgery and wound healing complications, hemorrhage, arterial and venous thromboembolic events, hypertension, renal injury and proteinuria, posterior reversible encephalopathy syndrome, ovarian failure, infusion-related toxicities, embryo-fetal toxicity, and congestive heart failure.

Prior bevacizumab-based data from clinical trials showed the following results:²

In the randomized phase 3 AVF2107g trial (NCT00109070), the median overall survival (OS) with bevacizumab plus irinotecan, fluorouracil, and leucovorin was 20.3 months compared with 15.6 months with placebo and chemotherapy (HR, 0.66; 95% CI, 0.54-0.81; P <.001) in patients with previously untreated metastatic CRC.

In the randomized phase 3 ML18147 trial (NCT00700102), bevacizumab with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy demonstrated a median OS of 11.2 months vs 9.8 months with chemotherapy alone (HR, 0.81; 95% CI, 0.69-0.94) in patients with metastatic CRC who progressed on an bevacizumab-containing regimen in the first-line setting.

In the randomized phase 3 E4599 trial (NCT00021060), bevacizumab with carboplatin and paclitaxel elicited a median OS of 12.3 months vs 10.3 months with paclitaxel and carboplatin alone (HR, 0.80; 95% CI, 0.68-0.94; P = .013) in unresectable, locally advanced, recurrent or metastatic non–squamous NSCLC.

In the randomized phase 3 EORTC 26101 trial (NCT01290939), there was no observed difference in OS (HR, 0.91; P = .4578); however, progression-free survival (PFS) with bevacizumab and lomustine (Gleostine) was 4.2 months vs 1.5 months with lomustine alone in patients with recurrent glioblastoma.

In the randomized phase 3 BO17705 trial (NCT00738530), bevacizumab with interferon α elicited a median PFS of 10.2 months vs 5.4 months with placebo with interferon α (HR, 0.60; 95% CI, 0.49-0.72; P <.0001) in patients with metastatic renal cell carcinoma; the overall response rate (ORR) was 30% vs 12%, respectively (P <.0001).

In the randomized phase 3 GOG-0240 trial (NCT00803062), bevacizumab with chemotherapy demonstrated an OS of 16.8 months compared with 12.9 months with chemotherapy alone (HR, 0.74; 95% CI, 0.58-0.94; P = .0132) in patients with persistent, recurrent, or metastatic cervical cancer. The ORR was 45% vs 34%, respectively.

In the randomized phase 3 GOG-0218 (NCT00262847) trial, bevacizumab with carboplatin and paclitaxel followed by bevacizumab monotherapy elicited a median OS and PFS of 43.8 months and 18.2, respectively; bevacizumab with carboplatin and paclitaxel elicited a median OS and PFS of 38.8 months and 12.8 months; and carboplatin and paclitaxel alone elicited a median OS and PFS of 40.6 months and 12.0 months in patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer after initial surgical resection.

In the randomized phase 3 MO22224 trial (NCT00976911), bevacizumab with chemotherapy elicited a median PFS of 6.8 months vs 3.4 months with chemotherapy alone (HR, 0.38; 95% CI, 0.30-0.49; P <.0001) in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received 2 or less prior chemotherapy regimens.

In the randomized phase 3 AVF4095g trial (NCT00434642), bevacizumab with chemotherapy elicited a median PFS of 12.4 months compared with 8.4 months with placebo with chemotherapy (HR, 0.46; 95% CI, 0.37-0.58; P <.0001) in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

References

1. Biocon Biologics announces U.S. FDA approval for Jobevne™, biosimilar bevacizumab, expanding Its oncology portfolio. News release. Biocon Biologics. April 10, 2025. Accessed April 10, 2025. https://tinyurl.com/2pxxm4jp
2. Avastin. Prescribing information. FDA. Accessed April 10, 2025. https://tinyurl.com/mrh4t8ue