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Global regulators and coalition of pharma and vaccine manufacturing associations come together to discuss COVID-19 pandemic response (July 2021)

On 7 July 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) is hosting a (virtual) workshop titled ‘Enabling Manufacturing Capacity in the COVID-19 Pandemic’ with representatives from the leading association bodies representing biotech firms, developing and industrialized countries vaccine manufacturers, as well as innovative biopharmaceutical, generic and biosimilar companies.

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IGBA Launches a Whitepaper: a Vision for the Global Generic and Biosimilar Medicines Industry (July 2021)

Today the International Generic and Biosimilar Medicines Association (IGBA) is launching a whitepaper:  A Vision for the Global Generic and Biosimilar Medicines Industry, which covers the strong contribution of this pharmaceutical sector to global health outcomes and economies, the opportunities, challenges and disruptions for the industry, its 2030 vision as well as actions needed to achieve this vision.

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IGBA Applauds UK MHRA Biosimilar Guidance Revision: Science-driven Evolution for Sustainable Access to Biologics (May 2021)

The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, welcomes the UK MHRA publication of its updated guidance on the licensing of biosimilar products (10 May 2021). This publication marks a positive milestone in the evolution of evidence requirements for biosimilar approval through the removal of the default need for a comparative efficacy trial, instead basing approval on a comprehensive comparability exercise, including a comparative pharmacokinetics (PK) trial.

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

C/O DYN SA
Rue de Cornavin 11
1201 Geneva, Switzerland

Telephone: +32 (0)2 5346607 (S. Kox)
E-mails: 
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or  
Secretary General –   This email address is being protected from spambots. You need JavaScript enabled to view it.

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