Respiratory

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FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

June 20th 2024

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

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Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships

June 6th 2024

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Eye on Pharma: Biosimilar Ozempic; Celltrion Omalizumab Biosimilar Submission

April 4th 2024

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Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart

October 10th 2023

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Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz

July 12th 2023

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