On Monday April 17, 2023, Celltrion announced that it has launched VEGZELMA (bevacizumab-adcd, an AVASTIN biosimilar) in the United States for the treatment of several cancers, including metastatic colorectal cancer and breast cancer. As we previously reported, VEGZELMA was approved by the U.S. Food and Drug Administration in September 2022…
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris. Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022. The CRL relates…
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of metastatic colorectal cancer, non-small cell lung cancer, and more. Japan is home to the world’s second largest bevacizumab…
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma. Celltrion has secured sales licenses for Vegzelma in 35 countries,…
As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…
Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). There are no FDA-approved ophthalmic formulations of bevacizumab currently…
Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States: ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech’s AVASTIN product. ALYMSYS is a vascular endothelial growth factor inhibitor approved by the FDA in April 2022 for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent…
Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: 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…
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).” As we previously reported, Outlook…