Celltrion USA obtains FDA OK for Avastin biosimilar
The Food and Drug Administration has given the green light to Celltrion USA for Vegzelma (bevacizumab-adcd), a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.
[Read more: AAM report: Generics, biosimilars saved U.S. healthcare system $8B in 2020]
“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,” said professor Claire Verschraegen, director of the division of medical oncology at the Ohio State University Comprehensive Cancer Center. “With the availability of biosimilars such as Vegzelma in the United States, oncologists will have additional treatment options for patients across multiple cancer types.”
“The approval of Vegzelma is an important milestone in the United States, 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 United States and contribute to a more sustainable healthcare system for the future.”
[Read more: AAM report: Medicare plans lag in adopting new generics]
The product will be launched in the first half of 2023.