Biosimilar(s) definition

Biosimilar(s) means a Prescription Drug(s) whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods and approved under the guidelines of the FDA provided by the Biologics Price Competition and Innovation Act (BPCI Act). Pursuant to the BPCI, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. FDA will require licensed biosimilar and interchangeable biological products to meet the Agency’s exacting standards of safety and efficacy. Biologics Price Competition and Innovation Act (BPCI Act) refers to the pathway as provided under the Patient Protection and Affordable Care Act (Affordable Care Act), signed into law on March 23, 2010, which amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).
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Biosimilar(s). – means a Prescription Drug(s) whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods and approved under the guidelines of the FDA provided by the Biologics Price Competition and Innovation Act (BPCI Act). Pursuant to the BPCI, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. FDA will require licensed biosimilar and interchangeable biological products to meet the Agency’s exacting standards of safety and efficacy. Biologics Price Competition and Innovation Act (BPCI Act) refers to the pathway as provided under the Patient Protection and Affordable Care Act (Affordable Care Act), signed into law on March 23, 2010, which amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).
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Related to Biosimilar(s)

  • Biosimilar means a biological product that is highly similar to a specific reference biological

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Licensed Compound means [***].

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • Licensed Antibody means (a) any Licensed Program Antibody and (b) any other Antibody that is a variant, fragment, derivative or other modification of a Licensed Program Antibody, that (i) Targets the Licensed Target, (ii) is made by or on behalf of Celgene or its Affiliates or Sublicensees during the Term in the course of its activities performed under this Agreement (or during the term of the Licensed Program U.S. License Agreement in the course of its activities performed thereunder) and (iii) is claimed (or was claimed in an issued Patent that has subsequently expired) as a composition of matter in a Licensed Program Patent set forth on Schedule 1.46(b), a Prothena Licensed Collaboration Patent set forth on Schedule 1.63, or Joint Program Patent (as defined in the Master Collaboration Agreement) as applicable, or any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such Licensed Program Patents, Prothena Licensed Collaboration Patents or Joint Program Patents (as defined in the Master Collaboration Agreement).