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  2. www.fda.gov › media › 169599FDA Drug Topics: Biosimilars: A Review of Scientific ...

    3 Learning Objectives. Review the key definitions, nomenclature, labeling, issues of interchangeability, and similarities and differences between biosimilars and reference biologics. Describe...

  3. www.fda.gov › media › 82647Scientific Considerations in Demonstrating Biosimilarity to a ...

    biosimilar to or interchangeable with a reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for an application for a

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  5. www.ncbi.nlm.nih.gov › pmc › articlesAn Overview of Biosimilars—Development, Quality, Regulatory ...

    Feb 11, 2024 · Clinical studies conducted for biosimilars aim to establish similar efficacy, safety, and immunogenicity, rather than demonstrating a clinical benefit, as with the reference product.

    • 10.3390/ph17020235
    • 2024/02

  6. www.fda.gov › files › drugsBiosimilar Product Regulatory Review and Approval - U.S. Food ...

    A clinical study or studies sufficient to demonstrate safety, purity, and potency of the proposed biosimilar product in one or more of the indications for which the reference product is...

    • 206KB
    • 2

  7. www.ncbi.nlm.nih.gov › pmc › articlesBiosimilars: Key regulatory considerations and similarity ...

    Sep 19, 2017 · The clinical assessment of similarity of a proposed biosimilar to the reference product involves comparative PK/PD, immunogenicity, and efficacy and safety studies.

    • Carol F. Kirchhoff, Xiao-Zhuo Michelle Wang, Hugh D. Conlon, Scott Anderson, Anne M. Ryan, Arindam B...
    • 10.1002/bit.26438
    • 2017
    • 2017/12

  8. www.ncbi.nlm.nih.gov › pmc › articlesKey concepts in biosimilar medicines: What physicians must ...

    Feb 10, 2022 · Currently, a product can be considered biosimilar to a reference product if there are no clinically meaningful differences in terms of safety, purity, and potency. In this review, the most important key concepts about biosimilars were summarized for physicians emphasizing the status in Turkey. Keywords: Biologic drugs, biosimilar, biotechnology.

  9. onlinelibrary.wiley.com › doi › fullBiosimilars: how similar is a biosimilar – a practical guide ...

    Sep 28, 2018 · A biosimilar medicine is a biological product that is designed to be similar to a biological medicine that has been granted consent to be marketed (the reference biologic).