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

  • 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.

  • In 2020, the agency did not list Somatuline Depot among the drugs that would be transitioned to Biologics Act regulation.

  • Pre-Litigation Patent-Related ProceduresThe Biologics Act attempts to streamline dispute resolution by placing specific procedures in place to guide the biosimilar applicant and reference product sponsor through the pre-litigation process.

  • Second, like the Drug Act, the Biologics Act also offers an abbreviated application process: when a company seeks to market a product that is “biosimilar” to or “interchangeable” with a product that has already been approved, it may submit an abbreviated biological license application(ABLA).

  • In other words, the Act required the FDA to, on March 23, 2020, transition substances that were approved as drugs, but now meet the current definition of “biological products,” to the Biologics Act.

  • Consistent with that mandate, on that date the FDA published a list of biological products that it deemed to be licensed under the Biologics Act, although they were initially approved under the Drug Act.

  • The Lead Party for each Collaboration Product will control all of the actions, filings, and communications with any follow-on biologic applicant under the Biologics Act with respect to such Collaboration Product, including generating the following documents: [***].

  • For companies using the Biologics Act, the FDA will play a key role in developing the regulations and policies that are critical to ensuring safe and efficacious biosimilar drugs.

  • Feldman & Misra, supra note 10, at 273 (“The challenges to biosimilars and thedisincentives in the Biologics Act are real.

  • We recommend output-based contracts as opposed to time-based contracts as observed with some Partners.

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;

  • WHS Act means the Work Health and Safety Act 2011 (Qld) or the Work Health and Safety (National Uniform Legislation) Act 2012 (NT), where applicable. WHS EPH means Workplace Health and Safety Entry Permit Holders under the WHS Act. Workplace Impairment Policy and Procedures means the Workplace Impairment Policy and Procedures found in APPENDIX 4.

  • 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.

  • FMC Act means the Financial Markets Conduct Act 2013.

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

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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);

  • PBR Act means the Plant Breeder’s Rights Xxx 0000 (Cth) as amended from time to time.

  • 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).

  • FOI Act means the Freedom of Information Act 2000 and any subordinate legislation made under that Act or any code issued pursuant to sections 45 or 46 of that Act or any guidance issued by the Information Commissioner;

  • Public Hospitals Act means the Public Hospitals Act (Ontario) and, where the context requires, includes the regulations made under it;

  • Corrupt Act means any offence in respect of corruption or corrupt activities contemplated in the Prevention and Combating of Corrupt Activities Act No. 12 of 2004;

  • FAIS Act means the Financial Advisory and Intermediary Services Act, 2002 (Act No. 37 of 2002);

  • 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.

  • ACNC Act means the Australian Charities and Not-for-profits Commission Act 2012 (Cth).

  • Public Health Laws means all applicable Laws relating to the development, pre-clinical testing, clinical testing, manufacture, production, analysis, distribution, importation, exportation, use, handling, quality, sale or promotion of any drug, biologic or medical device (including any ingredient or component of the foregoing products) intended for any medical or clinical use subject to regulation under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) or similar federal, state or foreign Laws.

  • 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.