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

  • Biosimilar drugs are manufactured after the patent and exclusivity protection of the BIOLOGIC drug have expired.

  • Biosimilar, interchangeable drugA U.S. FDA-approved biosimilar drug that may be automatically substituted for the original brand- name biologic drug.

  • Either Party shall, within *** Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction.

  • If a Biosimilar Product to a Product is sold in any country in the Territory during the Product Royalty Term for such Product and country, the Product Royalties payable with respect to such Product in such country will be reduced by [***] for the remainder of such Product Royalty Term.

  • 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 in accordance
Biosimilar means a drug that is produced or distributed in accordance with a biologics license
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 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 FD&C 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 GNE or a Sublicensee; and (2) where GNE or its Sublicensees have not directly authorised or permitted such Third Party to market, manufacture and sell such product in the market in question.
Biosimilar means a drug that is produced or distributed
Biosimilar means, with respect to a given Product in a given country of the Territory, any biological product on the market in such country that is approved (a) by the applicable Regulatory 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 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 by a Regulatory Authority in another country or jurisdiction. Any product or component thereof (including any Product or component thereof) licensed, marketed, sold, manufactured, or produced by or on behalf of a Party, its Affiliates or (sub)licensees will not constitute a Biosimilar.