GaBI - Generics and Biosimilars Initiative

14/08/2025

Trump’s ‘One Big Beautiful Bill’: implications for US health care

On 4 July 2025, US President Donald Trump signed into law a tax and spending package designed to fulfil several of his electoral campaign promises....

11/08/2025

Generics, Biosimilars and Follow-­ On Non-­ Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists

08/08/2025

Medicines For No-One

ASBM Steering Committee Members Andrew Spiegel, Executive Director of the Global Colon Cancer Association (GCCA); and Marcia Horn, CEO of the International C...

06/08/2025

MHRA issues guidance for decentralized manufacturing

These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (“CTRs”). These Regulations make provision for medicinal products that are manufactured in a modular unit, to enable depl...

04/08/2025

Senate HELP Committee Recommendations for 340B Reforms

WASHINGTON – Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a...

01/08/2025

Samsung Bioepis wins Pyzchiva case; Regeneron patent rulings threaten foreign biosimilars

A US court denied J&J's injunction against Samsung Bioepis, clearing Pyzchiva's launch. However, Regeneron's win against Samsung/Formycon s...

30/07/2025

Regulación de biosimilares en Argentina: el enfoque de ANMAT

En los últimos años, los biosimilares se han convertido en un componente esencial de los sistemas de salud sostenibles. En Argentina, la Administra...

28/07/2025

Canadá se dispone a eliminar el requisito de ensayos de fase III para los biosimilares

El 10 de junio de 2025, Health Canada publicó el 'Documento de orientación: Requisitos de información y presentación de medicamentos biológicos bio...

25/07/2025

Regulating biosimilars in Argentina: ANMAT’s approach

In recent years, biosimilars are an essential component of sustainable healthcare systems. In Argentina, the National Administration of Drugs, Food...

23/07/2025

Canada poised to remove requirement for Phase III trials for biosimilars
https://gabionline.net/guidelines/canada-poised-to-remove-requirement-for-phase-iii-trials-for-biosimilars

18/07/2025

Sustainability and Resilience in the Saudi Arabian Health System

16/07/2025

Asociaciones y adquisiciones de Alvotech: Dr Reddy’s, Advanz, Xbrane

Alvotech y Dr Reddy's colaboran para desarrollar un biosimilar de Keytruda. Alvotech completa la adquisición de Xbrane I+D y amplía su alianza con...