Center for Biosimilars

Biosimilar ABP 654 Maintains Efficacy, Safety After Repeated Switching From Ustekinumab

Trial data show switching between ABP 654 and reference ustekinumab maintains similar psoriasis control, safety, and ...
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

Rabiah Dys, PharmD

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

Peter Pitts

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

Corey Greenblatt, MPH

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

The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars

Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the ...
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

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry. The biosimilar market could be accelerated through patent litigation ...