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

April Breyer Menon, JD

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

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

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 The FDA has issued draft guidance that ...
centerforbiosimilars

The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more ...
centerforbiosimilars

FDA Approves 10th Adalimumab Biosimilar, Simlandi

After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th ...