Biosimilar Regulatory solution center
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Do Patient Needs Define Biologic Product Specifications?
3/14/2025
Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.
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Trends In FDA FY 2024 Inspection-Based Warning Letters
3/7/2025
Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.
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AI Performance Management In Biologic And Drug Development
3/7/2025
Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.
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The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly
3/3/2025
In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.
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What FDA Draft Guidance Tells Us About In-Process Control Strategies
2/28/2025
The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.
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U.S. Biosimilars Surge: Clinical Trials, Regulatory Shifts, And The Path To Dominance
2/28/2025
Joseph Pategou asks and answers, "Where does the U.S. biosimilar market stand now?"
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Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making
2/27/2025
The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.
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Strengthening Shop-Floor QA From The Ground Up
2/24/2025
Quality is created where and when manufacturing happens, not later through inspection. This approach integrates the QA function into daily production operations.
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Key Regulatory Considerations For The Next Wave Of Gene Therapies
2/21/2025
The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.
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10 Ways To Speed Up CMC In Early-Stage Drug Product Development
2/21/2025
The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.