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IGBA seeks framework waiving bridging trials

 
• By Aidan Fry

A new international regulatory framework for waiving biosimilar bridging studies has been proposed by the International Generic and Biosimilar Medicines Association (IGBA) in comments submitted to a US Food and Drug Administration (FDA) docket on facilitating competition and innovation in the biological products marketplace. This would allow such studies to be waived “in specific circumstances, based on core scientific and regulatory principles established for current products”. The IGBA’s call for a framework came in response to the FDA having asked for comments on what additional steps the agency could take “to facilitate multinational development programs that may include non-US-licensed comparators, to help support development of biosimilar products?” The FDA has invited comments via docket FDA-2018-N-2689 following a public hearing on biosimilar competition held in early September (Generics bulletin, 14 September 2018, page 8).

A new international regulatory framework for waiving biosimilar bridging studies has been proposed by the International Generic and Biosimilar Medicines Association (IGBA) in comments submitted to a US Food and Drug Administration (FDA) docket on facilitating competition and innovation in the biological products marketplace. This would allow such studies to be waived “in specific circumstances, based on core scientific and regulatory principles established for current products”. The IGBA’s call for a framework came in response to the FDA having asked for comments on what additional steps the agency could take “to facilitate multinational development programs that may include non-US-licensed comparators, to help support development of biosimilar products?” The FDA has invited comments via docket FDA-2018-N-2689 following a public hearing on biosimilar competition held in early September (Generics bulletin, 14 September 2018, page 8).

At present, the IGBA observes in a reflection paper submitted to the docket, biosimilar sponsors using a foreign reference drug...

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