Biotherapeutic Product definition

Biotherapeutic Product means (a) any therapeutic or prophylactic product for treatment or prevention of diseases or conditions in humans that comprises or incorporates (i) an antibody against a Mammalian Target, or (ii) an antisense compound based upon a Mammalian Target sequence, or (b) a gene therapy product based upon the sequence of a Mammalian Target.
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Biotherapeutic Product means [ * ].
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Biotherapeutic Product means the dosage form of an immunogenic product in the final immediate packaging intended for marketing.
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Examples of Biotherapeutic Product in a sentence

  • The application must include information demonstrating biosimilarity, based on data derived from, among other things, analytical studies that demonstrate that the biotherapeutic product is highly similar to the Reference Biotherapeutic Product notwithstanding minor differences in clinically inactive components.

  • Administrative Order No. 2014-0016 defines head-to-head comparability exercise as the direct head-to-head comparison of a biotherapeutic product with a licensed originator product also known as the Reference Biotherapeutic Product (RBP) with the goal to establish similarity in quality, safety, and efficacy.

  • These guidelinesare composed of template (Appendix 2) of the Summary Information for Similar Biotherapeutic Product (SIB) of which general information of the product should be filled out by Marketing Authorization Holder (MAH).

  • These guidelines are composed of template (Appendix 2) of the Summary Information for Similar Biotherapeutic Product (SIB) of which general information of the product should be filled out by the Applicant.

  • The BPCI act defines biosimilar as any biological product demonstrated to be highly similar and having no clinically meaningful differencesbetween a biological product and reference product in terms of the safety, purity, and potency of the product as demonstrated through clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics)9.World Health Organization (WHO) designates biosimilars as ‘Similar Biotherapeutic Product (SBP)’.

  • The Committee may exclude the financial performance of an acquired business, if material, at the time of the transaction.

  • Biosimilar, also known Similar Biotherapeutic Product (SBP), is highly similar to an original biotherapeutic product (that is, the Reference Biotherapeutic Product or RBP) and has been developed and assessed according to the regulatory guidelines that ensure an adequate comparison of the SBP with its RBP.

  • These guidelines are composed of template (Appendix 2) of the Summary Information for Similar Biotherapeutic Product (SIB) of which general information of the product should be filled out by Marketing Authorization Holder (MAH).

  • Risks Related to Regulatory Approval of Our Pharmaceutical and Biotherapeutic Product Candidates and Other Legal Compliance Matters The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable.

  • Similar Biotherapeutic Products (SBPs) can be approved based, in part, on an exercise to demonstrate similarity to an already approved Reference Biotherapeutic Product (RBP) by Stringent Regulatory Authorities (SRAs).


More Definitions of Biotherapeutic Product

Biotherapeutic Product. Biotherapeutic Product means (a) a Therapeutic Antibody Product, (b) a Therapeutic Antisense Product, (c) a Therapeutic Protein Product, and/or (d) a Therapeutic Other Molecular Product, as the case may be.
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Biotherapeutic Product means a biotherapeutic product medicinal product with the indications of treating human diseases
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Related to Biotherapeutic Product

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Therapeutic school means a residential group living facility:

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Licensed Compound means [***].

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Therapeutic equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.