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.

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.

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.