FDA Approves Mvasi, a Biosimilar of Avastin Co-developed by Amgen, Allergan

September 22, 2017: By Jon Swedien

Allergan AmgenAmgen and Allergan announced Sept. 14 that the US FDA has approved Mvasi, the companies’ biosimilar version of Roche’s Avastin.

Avastin (bevacizumab), an inhibitor of vascular endothelial growth factor marketed by Roche’s Genentech division, is indicated for various cancers and is used off label to treat retinal disease.

Mvasi is the first anti-cancer biosimilar drug and first biosimilar of Avastin approved in the US, the companies said.

Mvasi has received FDA approval for squamous non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent, or metastatic carcinoma of the cervix.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

Eylea Gains Approval in China for DME-Related Visual Impairment

Second Trial for Ophthalmic Industry Leader James Mazzo Ends in Hung Jury, Mistrial

Melgen Receives 17-Year Sentence for Medicare Fraud

NIH’s National Eye Institute Solicits Next-Generation Retina Organoids in $1 Million Prize Competition

Taiwan Liposome Company Registers for $50 Million IPO in US

US FDA Approves Icon Bioscience’s DEXYCU for Post-Cataract Surgery Inflammation

FDA’s Gottlieb Appears to Soften Stance on Compounding for Office Use

Genentech’s RG7716 Outperformed Ranibizumab in Phase II Study in Diabetic Macular Edema

Santen Reports Promising Data in Phase I/II Study in Refractory Wet AMD

Q Biomed Signs Agreement with Washington University for Novel Biomarker for Monitoring Glaucoma

pSivida’s Durasert for Posterior Segment Uveitis Yields Positive 12-Month Results in Second Phase III Study

Foundation Fighting Blindness Provides $7.5 Million to Help Develop ProQR’s Candidate for Usher Syndrome

Presbia Names Casey Lind as Chief Operating Officer, Magda Michna, MD, PhD, as Chief Clinical Officer

Astellas Acquires Universal Cells

Pixium Vision Completes Two Successful PRIMA Implantations in Atrophic Dry AMD Patients

Omeros Loses Pass-through Status for Omidria

USC Donations Drop $100 Million after Puliafito Scandal, Report Says

Regeneron’s US Eylea Sales Increase 14 Percent in Q4-2017

Allergan’s Net Sales Climb 12 Percent in Q4-2017; Restasis Sales Grow Nearly 1 Percent

Lucentis’ US Sales Drop 11 percent in Q4-2017, Grow 1 Percent for Full 2017

Coming soon

2018 Retinal Surgical Devices Report: A Global Market Analysis for 2017 to 2023