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…
On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed biosimilar to Roche’s AVASTIN®, in the United States, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and…
Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA. LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection formulation of bevacizumab for the treatment of wet AMD and other retinal diseases. In response to FDA’s request, Outlook…
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents the third bevacizumab biosimilar approved in the U.S, following Pfizer’s ZIRABEV (bevacizumab-bvzr) in 2019 and Amgen’s MVASI…
On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases. The statement alleges that certain large healthcare…
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Yesterday, the parties filed a Joint…
Amneal Pharmaceuticals, Inc., a fully integrated pharmaceutical company headquartered in Bridgewater, NJ, announced last week that the U.S. FDA has accepted its aBLA seeking approval of a biosimilar of Avastin® (bevacizumab). This biosimilar was developed in collaboration with Spain-based biopharmaceutical company mAbxience, which had obtained approval earlier this year to…
The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube…