Biosimilars

  • Points to Consider for Establishing Biotechnological/Biological Product Comparability

    Points to Consider for Establishing Biotechnological/Biological Product Comparability

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  • Points to Consider When Mitigating Biopharmaceutical Virus Risk

    Points to Consider When Mitigating Biopharmaceutical Virus Risk

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  • Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS

    Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS

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  • One step closer to a refined US Biosimilar Landscape

    One step closer to a refined US Biosimilar Landscape

    Navigating the commercial viability of the biologics market, in the context of a robust regulatory strategy to ensure a successful approval process for your biosimilar should not be tackled without th

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  • Marketing Authorization In The United States

    Marketing Authorization In The United States

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  • Quality By Design Case Study

    Quality By Design Case Study

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  • Rapid Global Access To Biosimilars Demands Agile, Integrated Development Strategies

    Rapid Global Access To Biosimilars Demands Agile, Integrated Development Strategies

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  • Key Considerations In US Biosimilars Development

    Key Considerations In US Biosimilars Development

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  • PAREXEL's Regulatory Expertise & Experience

    PAREXEL's Regulatory Expertise & Experience

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  • Accelerating the Biosimilar Journey

    Accelerating the Biosimilar Journey

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  • PAREXEL - How Similar is Biosimilar? EU versus US11:08

    PAREXEL - How Similar is Biosimilar? EU versus US

    In this short video, PAREXEL expert Dr. Cecil Nick, Vice President-Biotechnology, compares current FDA & EMA requirements for biosimilars.

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