FDA Approves Celltrion Biosimilar for Avastin, Vegzelma

The FDA approved Celltrion Healthcare’s Vegzelma (bevacizumab-adcd; CT-P16), a biosimilar referencing Genentech’s Avastin. The approval marks the fourth bevacizumab biosmilar to be approved in the United States.

Additionally, Vegzelma is the second bevacizumab product, the fifth oncology biosimilar, and sixth biosimilar overall to be approved in 2022. Earlier this year, Stimufend (pegfilgrastim-fpgk) was approved in September 2022, Cimerli (ranibizumab-eqrn) was approved in August, Fylnetra (pegfilgrastim-pbbk) was approved in June, Alymsys (bevacizumab-maly) was approved in April, and Releuko (filgrastim-ayow) was approved in March.

Vagzelma has 6 indications, including:

• Metastatic colorectal cancer
• Recurrent or metastatic nonsquamous non–small cell lung cancer
• Recurrent glioblastoma
• Metastatic renal cell carcinoma
• Persistent, recurrent, or metastatic cervical cancer
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer

“Biosimilars have been used in many disease areas including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world….With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types,” Claire Verschraegen, MD, MS, FACP, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, said in a statement.

Vegzelma marks the third Celltrion-developed biosimilar to receive FDA authorization, following the approvals of Truxima (rituximab-abbs) in November 2018 and Herzuma (trastuzumab-pkrb) in December 2018. Both Truxima and Herzuma are a part of a commercialization agreement between Celltrion Healthcare and Teva Pharmaceuticals, in which Teva will be responsible for US marketing.

Celltrion noted that Vegzelma was also available in the European Union in August 2022 and in the United Kingdom and Japan in September 2022.

“The approval of Vegzelma is an important milestone in the U.S. which adds to our growing portfolio of oncology treatments and marks an important step forward in expanding access to cancer care…," commented Jaeik Shim, chief operating officer at Celltrion USA. "We look forward to working with payers and providers to make our product available to patients. With our high-quality and affordable biosimilar medicines, we plan to strengthen our presence in the U.S. and contribute to a more sustainable healthcare system for the future."