Biosimilar development companies report an approval in Canada and positive phase 3 findings in China for their bevaciumab biosimilars.
Health Canada has approved a bevacizumab biosimilar (Bambevi) from Apobiologix, a division of Apotex, the company said in a statement. Referencing Avastin, the agent is approved for use in combination with chemotherapy for the treatment of colorectal, lung, brain, and ovarian cancer.
Apobiologix launched a filgrastim biosimilar (Grastofil) in Canada in 2016. That was followed up by the launch of a pegfilgrastim biosimilar (Lapelga) in 2019. Filgrastim and pegfilgrastim replenish the body’s supply of neutrophils, or white blood cells, which aid in the immune system’s fight against infection. Depleted white blood cell count, or neutropenia, is a condition associated with patients exposed to chemotherapy and radiation.
Trial Evidence Supports Boyounuo
Investigators said a bevacizumab biosimilar (LY01008, Boyounuo) has demonstrated comparable safety, efficacy, immunogenicity, and pharmacokinetics to the reference product Avastin in patients with non–small cell lung cancer (NSCLC).
The biosimilar has previously been approved for 4 indications by China's National Medical Products Administration, most recently for the treatment of hepatocellular carcinoma. It also is approved for advanced, metastatic, or recurrent NSCLC; metastatic colorectal cancer; and recurrent glioblastoma. Boan Biotech and Luye Pharma have been involved in its development and marketing.
The findings come from a phase 3, randomized, double-blind trial that investigators said was the largest study to date comparing the proposed biosimilar with the reference product as first-line treatment of Chinese patients with NSCLC. The study also evaluated the bevacizumab agents in combination with chemotherapy.
From December 2017 to May 2019, 649 patients were randomized 1:1 to receive the biosimilar or the reference product.
In 2020, a third of global lung cancer deaths occurred in China. Bevacizumab is considered the standard of care for advanced or recurrent nonsquamous NSCLC.