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Follow-on protein products: scientific issues, developments and challenges.

Anurag S Rathore1

  • 1Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, 110016, India. asrathore@biotechcmz.com

Trends in Biotechnology
|October 23, 2009
PubMed
Summary

Understanding biosimilar quality attributes is key for regulatory approval. This study addresses challenges in data standardization and non-clinical testing for protein-based therapeutics, offering recommendations to improve safety and efficacy assessments.

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