Posters
BIOSIMILARS: Global Terminology, Strategy & Pathways
Download the Global Terminology, Strategy & Pathways Poster
Features Baxter's Kelly Davis, Regulatory Affairs, Associate Director, and outlines:
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Biosimilar definition
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US and Europe Regulatory Pathways
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Biologics Price Competition and Innovation Act
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351(k) Application Requirements
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This whitepaper discusses considerations for development of a lyophilized biosimilar, as well as a biosimilar case study.
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85+ years of expertise in process and formulation development, technology transfer, and parenteral manufacturing.
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When different drug products are produced in shared facilities, the potential for cross contamination is always a concern.
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Work with a Global Leader in Syringe Fill/Finish
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A Global Leader in Sterile Contract Manufacturing
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Complex Sterile Manufacturing with More Than 60 Years of Oncology Experience
