Bevacizumab Biosimilar Avzivi Receives Positive CHMP Opinion

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the biosimilar Avzivi, a monoclonal antibody referencing the biologic bevacizumab (Avastin). The recommendation will now be brought to the European Commission, which will determine whether to grant marketing authorization to the biosimilar for the treatment of patients with colon or rectum cancer, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, epithelial ovarian fallopian tube or primary peritoneal cancer, and cervix cancer.^1,2

If approved, the drug will be available as a 25 mg/mL concentrate solution for infusion.²

“Bio-Thera is committed to developing high-quality biosimilars to expand patient access to important therapeutics like bevacizumab,” Shengfeng Li, chief executive officer of Bio-Thera Solutions, said in a news release.¹ “The positive CHMP recommendation for Avzivi demonstrates that commitment to patients, health care providers, and health care systems in Europe.”

The positive opinion was based on the totality of analytical, non-clinical, and clinical evidence showing that Avzivi is a biosimilar of the reference product, bevacizumab. The data package included extensive analytical characterization of the structural, physicochemical, and biological properties of Avzivi; findings from a randomized, double-blind, single-dose, three-arm, parallel-group phase 1 trial comparing the pharmacokinetics, safety, and immunogenicity of Avzivi with both the European Union and United States reference product in healthy individuals; and findings from a randomized, double-blind, multi-dose, three-arm, parallel-group phase 3 study comparing Avzivi with the reference product to substantiate equivalent efficacy and comparable pharmacokinetic, safety, and immunogenicity profiles, in patients with advanced nonsquamous NSCLC.

Bevacizumab currently holds several FDA-approved indications,³ including the treatment of patients with:

• Metastatic colorectal cancer (CRC) in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment;
• Metastatic CRC in combination with fluoropyrimidine-, irinotecan-, or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen;
• Unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC in combination with carboplatin and paclitaxel for first-line treatment;
• Recurrent glioblastoma in adults;
• Metastatic renal cell carcinoma in combination with interferon alfa;
• Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan;
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
  • in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent for stage III or IV disease following initial surgical resection;
  • in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; or
  • in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by bevacizumab as a single agent, for platinum-sensitive recurrent disease; and
• Hepatocellular carcinoma (HCC) in combination with atezolizumab (Tecentriq) for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.

In December 2023, the FDA approved Avzivi, representing Bio-Thera’s second FDA-approved therapy and the second Chinese-manufactured biosimilar to receive an indication in the US.⁴

In September 2021, Bio-Thera and Sandoz agreed to a licensing and commercialization partnership for Avzivi in which Bio-Thera will be responsible for the development and manufacturing of the product and Sandoz owns the right to commercialize the agent pending approval and successful Marketing Authorization Holder Transfer in the United States, Europe, Canada, and other select countries.

References

1. Bio-Thera Solutions receives positive CHMP opinion for Avzivi (bevacizumab), a biosimilar referencing Avastin. News release. Bio-Thera Solutions. June 3, 2024. Accessed June 3, 2024. https://www.prnewswire.com/news-releases/bio-thera-solutions-receives-positive-chmp-opinion-for-avzivi-bevacizumab-a-biosimilar-referencing-avastin-302161771.html
2. Avzivi bevacizumab. Summary of opinion. European Medicines Agency. May 30, 2024. Accessed June 3, 2024. https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-avzivi_en.pdf
3. Avastin. Prescribing information. Genentech; 2020. Accessed June 3, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s332lbl.pdf
4. FDA approves Bio-Thera solutions’ Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin. News release. Bio-Thera Solutions. December 7, 2023. Accessed June 3, 2024. https://www.prnewswire.com/news-releases/fda-approves-bio-thera-solutions-avzivi-bevacizumab-tnjn-a-biosimilar-referencing-avastin-302009433.html