centerforbiosimilars

Nancy J. Globus, PharmD

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
Center for Biosimilars

Biosimilar Makers Push Forward on Regulatory and Commercial Fronts

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting ...
centerforbiosimilars

Paul Cornes, BM, BCH, MA, MRCP, FRCR

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

James D. Chambers, PhD, MPharm, MSc

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Rabiah Dys, PharmD

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

April Breyer Menon, JD

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Saro Arakelians, PharmD

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Corey Greenblatt, MPH

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Peter Pitts

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

FDA Approves First Eylea Biosimilars

The FDA approved the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions. The FDA announced that it ...
centerforbiosimilars

EMA Approves First Ustekinumab Biosimilar, Uzpruvo

The European Medicines Agency (EMA) has granted marketing authorization to the first ustekinumab biosimilar, STADA Arzneimittel and Alvotech’s Uzpruvo. The European Medicines Agency (EMA) granted ...
centerforbiosimilars

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability. The FDA has issued draft guidance that ...