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IGBA Reflection Paper on waiving bridging studies for biosimilar medicines applications

IGBA proposes a new international biosimilars framework allowing bridging studies to be waived in specific circumstances based on core scientific and regulatory principles established for current products.

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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.

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

c/o Interexperts SA
Rue des Pierres-du-Niton 17
1207 Geneva, Switzerland

Telephone: +32 (0)2 5346607
E-mails: 
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