Search results for " approval"
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Biopharma Advances Demand Specialized Expertise
The approval of the first biosimilar in the United States, as well as continuing consolidation in the biopharma and contract development and manufacturing markets, are just two indicators of the ongoi…
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What’s In a Name? For Biosimilars, A Lot
In the United States, the United States Adopted Names Council (USAN) next names medicinal articles, usually also well before approval. When FDA approves a product, it assigns an interim established na…
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Quality Systems Key to Lifecycle Drug Management
This goal has not been realized, though, as seen in a continued rise in manufacturing supplements that require agency approval, and in multiple drug shortages linked to low quality manufacturing opera…
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Elucidating Biosimilars Characterization
NIBRT: Differences regarding the approval process for small molecules as compared to recombinant protein therapeutics are reflected in the complexity that must be considered when comparing small-molec…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
The percentage of biopharmaceutical candidates receiving accelerated approval designations has grown dramatically (2,3). Development timelines for these accelerated programs can be half that for tradi…
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Good Manufacturing Practices: Challenges with Compliance
Improvements and transition to new technologies take time and often require prior approval from global health authorities, which can present supply-chain challenges and may have implications on drug a…
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Gene Therapies Push Viral Vector Production
The latest approvals of gene therapies using AAV (e.g., Luxturna, Zolgensma) have led to a surge in AAV use as it has proven safe and effective,” adds Vicaire.
Based on recent approvals and the…
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Methods Accelerate Biosimilar Analysis
US biosimilar approval roadblocks
As of Aug. 1, 2019, FDA has approved 21 biosimilars; of these, only five are currently commercially available. Of the approved drugs, five are biosimilars of tras…
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
In 2017, FDA set a record for the number (31 approvals) and percent (93%) of approved biopharmaceuticals being recombinant-based compared with 18 approvals in 2003 and 69% for recombinant products (wi…
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Understanding Validation and Technical Transfer, Part 3
It stands to reason, however, that at the time of regulatory approval not all sources of process or product variability may be fully understood. For example, the impact of raw material variability or …