Reference Product definition

Reference Product means a biological Prescription Drug.

Reference Product means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which the interchangeable biological product was evaluated by the U.S. Food and Drug Administration pursuant to 42 U.S.C. § 262(k).

Reference Product means the single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application (section 351(i)(4) of the PHS Act).

Examples of Reference Product in a sentence

• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.

• All these marketing authorisations are considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10 of the directive, which lays down rules on data exclusivity and market protection and on the so-called European Reference Product.

• Drug products in solid oral dosage forms reviewed by the TPD according to the guidelines, “Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A and B” and have a Canadian Reference Product on the Notice of Compliance.

• Drug Products Without a Canadian Reference Product The following submission requirements pertain to products submitted for listing in an interchangeable grouping where the active ingredient is designated as an “old drug” by the TPD and the drug product is approved on the basis of DIN application (i.e. an NOC is not issued) or is issued a Notice of Compliance without a Canadian Reference Product.

• Drug products in Aqueous Solutions (e.g. oral, ophthalmics, inhalation, injections) that have a Canadian Reference Product on the Notice of Compliance.

More Definitions of Reference Product

Reference Product means the single biological product licensed

Reference Product has the meaning set forth in the definition of Generic Product.

Reference Product means Forteo® (teriparatide), as branded and approved in the Territory.

Reference Product means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.

Reference Product means the product currently marketed and sold under the pharmaceutical brand identified in the Amending Product Exhibit.

Reference Product means the reference brand biologic product for each Product, which as of the Effective Date are: (a) with respect to Momenta’s development compound referred to as “M834”, the fusion protein abatacept, as marketed and manufactured by or on behalf of Abatacept Innovator as Orencia®; (b) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (c) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (d) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (e) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; and (f) with respect to Momenta’s development compound referred to as [***], the [***] manufactured and marketed by or on behalf of [***] Innovator as [***] or [***].

Reference Product means Lucentis® (Ranibizumab), as approved in the applicable jurisdiction.