Biosimilar definition
Biosimilar means a biological product that is highly similar to a specific reference biological
Biosimilar means a biological product that is highly similar to a specific reference biological product, notwithstanding minor differences in clinically inactive compounds, such that there are no clinically meaningful differences between the reference biological product and the biological product that has been licensed as a biosimilar pursuant to 42 U.S.C. § 262(k) in terms of safety, purity, and potency of the product.
Biosimilar means a drug that is produced or distributed pursuant to a biologics license application
Examples of Biosimilar in a sentence
In no event will the aggregate amount of Royalty Payments due to Viridian for the Licensed Product in the Territory in any given Calendar Quarter during the Royalty Term be [***] of the amount that otherwise would have been due and payable to Viridian in such Calendar Quarter for the Licensed Product in the Territory but for the reductions set forth in Section 8.3.3(a) (Biosimilar Products) and Section 8.3.3(b) (Third Party Patent Rights).
More Definitions of Biosimilar
Biosimilar means a drug that is produced or distributed in accordance with a biologics license
Biosimilar means a drug that is produced or distributed in accordance
Biosimilar means a drug that is produced or distributed pursuant to a biologics license application approved under United States Code, title 42, section 262(K)(3).
Biosimilar means, with respect to a given biologic product, another biologic product, which does not differ in any clinically meaningful way from the given biologic product with respect to its amino acid sequence, analytical comparability, safety or efficacy and is being developed or approved for one or more indications for which the given biologic product is approved.
Biosimilar means, with respect to a given Licensed Product in a given country of the Territory, any biological product on the market in such country that is approved (a) by the applicable Competent Authority in such country under the biosimilarity standard set forth in the United States under 42 U.S.C. §§ 262(i)(2) and (k), or any similar standard under its foreign equivalent applicable Law, on a country-by-country basis where such Licensed Product is marketed, provided that such applicable Law exists; and (b) in reliance in whole or in part, on a prior Marketing Approval (or on any safety or efficacy data submitted in support of such prior Marketing Approval) of such Product. For countries or jurisdictions where no explicit biosimilar regulations exist, Biosimilar includes products which have been deemed to be a Biosimilar or otherwise deemed interchangeable by a Competent Authority in another country or jurisdiction. Any product or component thereof (including any Licensed Product or component thereof) licensed, marketed, sold, manufactured, or produced by or on behalf of a Party, its Affiliates or Sublicensees (to the extent such Sublicensee commercializes a Biosimilar in reliance on or access to the Data, Patents and Know-How licensed under this Agreement) will not constitute a Biosimilar.
Biosimilar means a drug that is produced or distributed
Biosimilar means a product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.