FDA's approach to regulating biosimilars

Clinical Cancer Research

Volumn 23, Issue 8, 2017, Pages 1882-1885

  Lemery, Steven J ^a   Ricci, M Stacey ^a   Keegan, Patricia ^a   McKee, Amy E ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT;

ARTICLE; CLINICAL STUDY; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG SAFETY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; LICENSING; NONHUMAN; PHARMACODYNAMICS; PHYSICAL CHEMISTRY; LEGISLATION AND JURISPRUDENCE; UNITED STATES;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85017932659     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-16-1354     Document Type: Article

References (10)

1. Sections 7002(a)(2) and (b)(3) of the Affordable Care Act, adding sections 351(k), 351(i)(2), and 351(i)(4) of the PHS Act.
2. U.S. Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product [PDF on the internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2015 [cited 2016 Jul 30]. Available from: http://www.fda.gov/ downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ ucm291128.pdf.
3. U.S. Food and Drug Administration. Guidance for Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 [PDF on the internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2015 [cited 2016 Jul 30]. Available from: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm444661. pdf.
4. U.S. Food and Drug Administration. Implementation of the Biologics Price Competition and Innovation Act of 2009. Silver Spring, MD: U.S. Food and Drug Administration; 2016 [cited 2016 Jul 30]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ ucm215089.htm.
5. U.S. Food and Drug Administration. Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product [PDF on the internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2015 [cited 2016 Jul 30]. Available from: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf.
6. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111-7.
7. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315-8.
8. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood 2014;124:3191-6.
9. U.S. Food and Drug Administration. Draft Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product [PDF on the internet]. Silver Spring,MD: U.S. Food and Drug Adminisration; 2014 [cited 2016 Jul 30]. Available from: http://www. fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm397017.pdf.
10. Lemery SJ, Esteva FJ, Weise M. Biosimilars: here and now. Am Soc Clin Oncol Educ Book 2016;35:e151-7.