Biosimilars

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25
Jun

Frances Zipp Shares Market Insights at the CPhI China Exhibition in Shanghai

By    Jun 25, 2019    Biosimilars Compliance Data Integrity Generics Regulatory Affairs

On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio […]

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24
May

The Treasure Map to Biosimilarity Just Got More Granular

By    May 24, 2019    Biosimilars BLA FDA Regulatory Affairs Science & Technology

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced.  The increased level of detail and wider breadth of topics gives a […]

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