Tagged as: IGBA

IGBA Urges FDA to Waive the Requirement for Bridging Studies for Biosimilar Sponsors

In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required…

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