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.

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

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.