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 in accordance

Examples of Biosimilar in a sentence

• Hospital Adalimumab (Humira® / Biosimilar) ICB Treatment of adults with psoriasis - as per NICE TA 146 and the local treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service.

• No prescribing in primary care TA146 - Jun 08 Hospital Adalimumab (Humira® / Biosimilar) ICB Severe active Crohn's disease which has not responded to conventional therapy - as per NICE TA 187 Restricted use – Prescribing to remain with the hospital or specialist service.

• No prescribing in primary care TA199 - Aug 10 Hospital Adalimumab (Humira® / Biosimilar) ICB Moderate to severe ulcerative colitis (primary) - as per NICE TA 329 Restricted use – Prescribing to remain with the hospital or specialist service.

• No prescribing in primary care TA329 - Feb 15 Hospital Adalimumab (Humira® / Biosimilar) NHSE Juvenile idiopathic rheumatoid arthritis (JIA) - option in children with chronic anterior uveitis - as per NHS England policy Restricted use – Prescribing to remain with the hospital or specialist service.

• No prescribing in primary care TA195 - Aug 10 Hospital Adalimumab (Humira® / Biosimilar) ICB Treatment of psoriatic arthritis (including switching between treatments) - as per local treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service.

More Definitions of Biosimilar

Biosimilar means a drug that is produced or distributed pursuant to a biologics license application

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 in accordance with a biologics license

Biosimilar means, with respect to a given Collaboration Product in a given country, 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 Collaboration 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 Collaboration 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 the United Sates or European Union. Any product or component thereof (including any Collaboration 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 for the purpose of royalty reduction pursuant to Section 8.1.1.

Biosimilar means a drug that is produced or distributed

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.