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IGBA Position on Identification of Biological, including Biosimilar Medicines 2018 Update of Facts & Figures

IGBA Position on Identification of Biological, including Biosimilar Medicines 2018 Update of Facts & Figures.

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IGBA submission to HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs [RIN 0991-ZA49]

16th July 2018. In its submission, IGBA invites the FDA to waive the requirement for bridging studies when a foreign-licensed reference comparator product is used for biosimilar development,  given that the locally licensed reference product and the foreign-licensed product are versions of the same product. This constitutes an important and effective development tool in reducing the development costs for biosimilars and interchangeable products, will increase competition and hence will improve access to these life-saving innovative treatments.

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Access, sustainability and manufacturing competitiveness highlighted at global generic, biosimilar and value added pharmaceutical conference in Budapest

Budapest, 14th June 2018. Industry leaders from the generic, biosimilar and value added medicines industries discuss challenges and opportunities in ensuring sustainable, worldwide patient access to pharmaceuticals. Medicines for Europe and the International Generic and Biosimilar Medicines Association (IGBA) join forces to tackle challenges such as market sustainability, medicines shortages, and international regulatory cooperation. Opportunities can be pursued with strong stakeholder collaboration for a sustainable industry. These include the introduction of an EU SPC manufacturing waiver, and ensuring that generic, biosimilar and value added medicines can play their role in providing better access for better health.   

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

Rue d'Arlon, 50
B-1000 Brussels, Belgium

Telephone: +32 (0)2 736 84 11
Fax: +32 (0)2 736 74 38
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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