Safe Biologics

FEBRUARY 4, 2025

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications.

Biosimilars 130

Biosimilars Immunity Immunization 130

Drug Patent Watch

DECEMBER 9, 2024

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. 2024, June 19). 2024, May 17).

Biosimilars 97

Biosimilars Immunity Immunization 97

European Pharmaceutical Review

JANUARY 11, 2024

The European Commission (EC) has granted a marketing authorisation for Uzpruvo ® (AVT04) in Europe, a biosimilar candidate to Stelara ® (ustekinumab). The biologic targets the p40 protein, which has key roles in treating immune-mediated diseases like Crohn’s disease, psoriasis as well as psoriatic arthritis, Alvotech highlighted.

Biosimilars 115

Biosimilars Immunity Immunization 115

Big Molecule Watch

SEPTEMBER 3, 2024

Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions.

Biosimilars 69

Biosimilars Immunity Immunization 69

Quality Matters

JUNE 17, 2024

Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? You’ve probably seen commercials for some of them on TV.

Biosimilars 52

Biosimilars Dosage Immunity Immunization 52

Big Molecule Watch

JANUARY 6, 2025

On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsens STELARA. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the FDA. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the FDA.

Biosimilars 45

Biosimilars Immunity Immunization 45

Express Pharma

OCTOBER 9, 2024

He addressed the CII 6th Pharma and Life Sciences Summit 2024 in New Delhi. He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space.

Vaccines 105

Vaccines Process Improvement Biosimilars Immunity 105