BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

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LATEST ARTICLES

Bioavailability as Proof to Authorize the Clinical Testing of Neurodegenerative Drugs

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Lectin-Based Fluorescent Comparison of Glycan Profile —FDA Validation

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Advice to the US FDA to Allow US Pharmacopeia to Create Biological Product Specifications (BPS)

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Top Cited Publications

Computer-Aided Drug Design and Drug Discovery: A Prospective Analysis

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Biosimilars and Interchangeable Biologics: Tactical Elements

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CURATED BOOKS

Biosimilars Development Strategies

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Handbook of Biological Therapeutic Proteins

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mRNA Therapeutics: Fast-to-Market Strategies

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LEGAL PETITION

FDA-2024-N-1869 Response for BLA 761248

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