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November-December 2024

Safe Biologics

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.

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Waters, as a strategic partner to the pharma industry, can help India become a world leader in biosimilars

Express Pharma

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

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The top 5 pharma M&A deals of 2020

pharmaphorum

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition.

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FDA Approves Celltrion’s STEQEYMA (ustekinumab-stba)

Big Molecule Watch

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. According to Celltrion, STEQEYMA is expected to be marketed in the United States beginning in February 2025.

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Why mAbs Matter

Quality Matters

To understand monoclonal antibody drugs, its necessary to first know a little about how antibodies work in the bodys immune system. The immune system protects the body from harmful substances, microbes and abnormal cells that can cause diseases. Anything that triggers an immune response is called an antigen.

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CHMP meeting highlights – January 2025

European Pharmaceutical Review

EMAs human medicines committee (CHMP) recommended eight medicines for EU marketing authorisation at its January 2025 meeting. Biosimilars given a positive opinion Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy.