Vegzelma became the fourth biosimilar referencing Avastin (bevacizumab) to be approved for use in the United States for several types of cancer.
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:
“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."
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio
March 13th 2024A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.
HLX02, Pertuzumab, Chemotherapy Combination Effective, Safe in Advanced HER2-Positive Breast Cancer
March 12th 2024A study found combining trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy was effective and safe for patients with HER2-positive metastatic breast cancer who progressed after prior trastuzumab therapy.