☆ 4.7 Review

Indian Biosimilars and Vaccines at Crossroads-Replicating the Success of Pharmagenerics

VACCINES (2023)

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Summary: This study examines the reasons for warning letters issued by the FDA to pharmaceutical companies after post-approval inspections. The most common reasons for the warning letters are poor compliance to CGMP and misbranding. Detailed analysis of CGMP warning letters reveals three major types of violations: deficiencies in process validation, documentation practices (data integrity), and quality control. The study emphasizes the importance of improving CGMP compliance and implementing effective quality management systems to avoid warning letters.

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Summary: Biosimilars are adaptations of original biologic medicines with remedial effects similar to the original drug. In the upcoming decade, more biologics will go off patents, providing opportunities for innovator firms. However, biosimilar firms face challenges in development, registration, and market competition. Factors such as regulatory strictness, investment allocation, and market maturity uncertainty hinder Indian biosimilar players from actively participating in global markets.

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SEMINARS IN ARTHRITIS AND RHEUMATISM (2015)

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Patent expiry dates for best-selling biologicals

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GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL (2015)

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