Celltrion’s Avastin Biosimilar Gets FDA Greenlight
The US FDA has approved Celltrion’s Vegzelma (bevacizumab-adcd), a bevacizumab biosimilar, offering patients with six types of cancer a cheaper but almost-indistinguishable treatment option to the original. Vegzelma was also approved in the EU in August and obtained approvals from the UK and Japan in September.
The US approval is Celltrion’s third in the oncology biosimilar space, after Truxima (rituximab-abbs) and Herzuma (trastuzumab-pkrb).
Approved Indications For Vegzelma
Vegzelma’s indications cover 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 was based on results from several trials, including a pivotal Phase 3 in nsNCLC, which showed that Vegzelma is highly similar to the reference product in terms of efficacy, safety, and pharmacokinetics.
“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,” said Jaeik Shim, Chief Operating Officer at Celltrion USA.
“As a leading force in the global biopharmaceutical industry, 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.”
Biosimilars Of Bevacizumab
Biosimilars are near-identical versions of an original biological product that show no clinically meaningful differences from their reference. Like generics, which are identical copies of small molecules, biosimilars are intended to drive down the costs of medication, and are typically introduced into the market at a discounted price.
Bevacizumab, developed by Genentech (a Roche company) under the brand name Avastin, was first approved in the US in 2006. To date, four biosimilars of the drug have been approved, including Mvasi (Amgen), Zirabev (Pfizer), Alymsys (Amneal), and Vegzelma (Celltrion). Several biosimilar candidates are currently under FDA review, including Samsung Bioepis’ Aybintio.
The increasing prevalence of biosimilars has eaten away at Avastin sales, with revenue decreasing from over $7 billion in 2015 to below $5.5 billion in 2020.
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