The US FDA Draft New Guidelines for Proposed Biosimilars and Interchangeable Insulins

 The US FDA Draft New Guidelines for Proposed Biosimilars and Interchangeable Insulins

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  • The objective of this guideline is to provide recommendations on when and whether a comparison clinical immunogenicity study is required for biosimilar and interchangeable insulin products targeted to treat Type 1 or Type 2 diabetes mellitus
  • The  US FDA stated that if an analytical study is based on state-of-the-art technology supporting “highly similar” for a biosimilar or interchangeable insulin then no clinical immunogenicity study will be required demonstrating minimal or no risk of clinical impact from immunogenicity. Additionally, include cases where immunogenicity study is required for products that show differences in certain impurities or novel excipients
  • The FDA expects BLAs for biosimilar and interchangeable insulins include adequate chemistry, manufacturing, control information, a comprehensive comparative analytical assessment, a comparative clinical pharmacology study, and an immunogenicity assessment
  • With these guidelines, Mar 2020, onwards approved NDAs for insulins will be “deemed to be licenses” under section 351(a) of the PHS Act and can be further used as reference products for seeking licensure of proposed biosimilar and interchangeable insulin products under section 351(k) of the PHS Act

Click here to­ read full press release/ article | Ref: The US FDA | Image: Twitter

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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