28 September 2022 - - The US Food and Drug Administration has approved Vegzelma (bevacizumab-adcd), a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer, US-based Celltrion USA said.

The six types include metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The FDA approval of Vegzelma was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nsNSCLC. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.

Vegzelma is Celltrion's third oncology biosimilar approved for use in the US, following the approval of Truxima (rituximab-abbs) and Herzuma (trastuzumab-pkrb).

Vegzelma was approved in the EU in August 2022 and UK and Japan in September 2022. Regulatory reviews are ongoing in additional countries.

About Vegzelma (CT-P16, biosimilar bevacizumab-adcd)2
Vegzelma is an anti-cancer monoclonal antibody treatment biosimilar to Avastin (bevacizumab).

Vegzelma is a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor, the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (VEGFR-2), on the surface of endothelial cells.

In the US, Vegzelma is indicated for the treatment of patients with metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma ; metastatic renal cell carcinoma ; persistent, recurrent, or metastatic cervical cancer ; epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies.

Its products are manufactured at mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice and the EU GMP guidelines.

Celltrion USA is South Korea-based Celltrion Healthcare's US subsidiary dedicated to the distribution of Celltrion's small molecule pharmaceutical products and biosimilar products within the US.

Celltrion USA started its business as a brand and generic pharmaceutical product distributor and expanded its portfolio to COVID-19 test kits. Celltrion USA will be dedicating its resources to biosimilar product launches in the US.