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 in accordance
Examples of Biosimilar in a sentence
In no event will the Royalties due to Adaptimmune in any Calendar Quarter with respect to any Licensed Product in the Field in a country in the Territory be reduced by more than (***) as a result of the operation of the reductions contemplated by Section 10.5.3(a) (Lack of Valid Claim), Section 10.5.3(b) (Biosimilar Product), and Section 10.5.3(c) (Third Party Rights) compared to what such Royalties would have been in such Calendar Quarter in such country without such reductions.
The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii).
More Definitions of Biosimilar
Biosimilar means a drug that is produced or distributed pursuant to a biologics license application
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 in accordance with a biologics license
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.
Biosimilar means any drug or biological product that is interchangeable directly with any Licensed Product and which is subject to review under an abbreviated approval pathway as a biosimilar, follow-on biologic or generic biological product, as those terms are commonly understood under the Food, Drug & Cosmetic Act or the PHS Act and related rules and regulations, or the corresponding or similar laws, rules and regulations of any other jurisdiction and (1) where such Biosimilar obtains Regulatory Approval or is otherwise sold by a Third Party that is not Licensee or a Sublicensee of Licensee; and (2) where Licensee or its Sublicensees(s) have not directly authorised or permitted such Third Party to market, manufacture and sell such product in the market in question. Kineta-Genentech Exclusive Option and License Agreement
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 a drug that is produced or distributed