Biologics Act definition

Biologics Act has the meaning set forth in Section 7.5.
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Biologics Act means the Biologics Price Competition and Innovation Act, 42 U.S.C. § 262, or the equivalent law in any jurisdiction in which Chondrial commercializes or intends to commercialize Licensed Products.
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Examples of Biologics Act in a sentence

  • The Biologics Act predates the regulation of drugs under the Pure Food and Drugs Act, which was enacted in 1906.

  • Prior to the Biologics Act, Congress made several short-lived attempts to regulate specific sectors of the prescription drug market, such as the safety of smallpox vaccine, 2 Stat.

  • The Biologics Act of 1902 was passed in response to the distribution of tetanus infected diphtheria antitoxin and required licensing of biological drugs sold in interstate commerce.

  • With the Biologics Act, the brand company controls the challenge process and can decide to assert whichever rights it chooses in whatever order it chooses, potentially across a series of legal battles.102 And of course, those rights are not conveniently listed upfront.In short, brand drugs in the Hatch-Waxman system must put all of their cards on the table; brand drugs in the Biologics system can hide their hands, playing cat-and-mouse games with follow-on drug companies.

  • In contrast, a biologic follow-on drug maker must meet the higher standards of biosimilarity or interchangeability.The pathway for rapid entry of generics is known as the Hatch- Waxman system;95 the biologic pathway is known by the more complex acronym, BPCIA (the Biologic Price Competition and Innovation Act, hereinafter the “Biologics Act”).96The Biologics Act provides greater protection for branded biologic drugs than Hatch-Waxman provides for branded non- biologic drugs.

  • Congress created that route to FDA licensure in the Biologics Act in 2010.

  • Thus, the greater protections available under the Biologics Act further encourage companies to pursue opportunities in the cancer space.

  • In 1941, three years prior to the re-codification of the Biologics Act, Congress gave the FDA authority over the marketing of insulin.26 Insulin is a peptide hormone, a small protein that regulates carbohydrate metabolism.27 In the 1940s, insulin “was obtained in the same manner as many biologics, namely extraction from animals.

  • The Biologics Act, however, is even more complex and convoluted than Hatch-Waxman and seems designed on en- tirely the wrong template.329 It took until September 2015—six years after the act’s passage—for the first biosimilar to reach the market.330 Simplification is not the instinct of lawyers in general nor of patent lawyers in particular.

  • Three years prior to the re-codification of the Biologics Act, Congress gave the FDA authority over the marketing of insulin.21 Insulin is a peptide hormone, a small protein that regulates carbohydrate metabolism.22 In the 1940s, insulin “was obtained in the same manner as many biologics, namely extraction from animals.

Related to Biologics Act

  • Cannabis Act means An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, S.C. 2018, c. 16, as amended from time to time.

  • OHS Act means the Occupational Health and Safety Act 2004;

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • HITECH Act means the Health Information Technology for Economic and Clinical Health Act, TitleXIII, Subtitle D, Part 1 & 2 of the American Recovery and Reinvestment Act of 2009.

  • FDA Act means the U.S. Federal Food, Drug, and Cosmetic Act, as amended.

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • Controlled Substances Act means the Controlled Substances Act (21 U.S.C. Sections 801 et seq.), as amended from time to time, and any successor statute.

  • Public Works Act means the Public Works Xxx 0000;

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • PPS Act means the Personal Property Securities Act 2009 (Cth).

  • POPI Act means the Protection of Personal Information Act, 4 of 2013;

  • Rail Safety Act means the Rail Safety Act 1998 (WA);

  • Licensed health care practitioner means a physician, as defined in Section 1861(r)(1) of the Social Security Act, a registered professional nurse, licensed social worker or other individual who meets requirements prescribed by the Secretary of the Treasury.

  • Gas Act means the Belgian Gas Law concerning the transportation of gaseous and other substances by pipeline of 12 April 1965, as amended from time to time.