Regulatory Open Forum

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  • 1.  Unbranded Authorized biosimilar or biologic

    Posted 26-Feb-2022 13:25
    Helle colleagues,

    What are the requirements for a company to market their own unbranded authorized biosimilar or biologic product?

    Thank you.

    Best regards.

    Davids Lucking

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    David Lucking
    Coral Gables FL
    United States
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  • 2.  RE: Unbranded Authorized biosimilar or biologic

    Posted 01-Mar-2022 08:03
    Hello David,

    I think that without some additional context, your question cannot be answered.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: Unbranded Authorized biosimilar or biologic

    Posted 02-Mar-2022 07:07
    I agree with Glen Park - need more context as to the question - approval steps? promotional rules? what?

    If promotional - the same rules for branded drugs/biologics apply to generics - both are drugs and one would start with 21 CFR 202.1 for the overarching promotional rules.  Just because you don't "brand" the generic, you would still be marketing under the established name of the product.

    Sincerely,
    Glenn

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    Glenn Byrd, MBA
    President, GByrd Ad-Promo Solutions, LLC
    Chair, RAPS Board of Directors
    United States
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    Original Message


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