Key considerations in biosimilars development

BioPharm International

Volumn 25, Issue 10, 2012, Pages 37-39

  Donninger, Raymond ^a   Bower, Joe ^a   Kaiser, Raymond ^a   Estdale, Sian ^a   Carlsen, John ^a  

^a Covance ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; ERYTHROPOIETIN; GENERIC DRUG;

ANALYTIC METHOD; ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; ECONOMIC ASPECT; GOVERNMENT REGULATION; IMMUNOGENICITY; PRODUCT DEVELOPMENT;

EID: 84872154392     PISSN: 1542166X     EISSN: 19391862     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (4)

1. Datamonitor, "Pharma. Key Trends 2011- Biosimilar Mrkt. Overview" (Feb. 2011).
2. FDA, Guidance for Industry: Scien. Consid. in Demon. Biosimilarity to a Reference Product (Rockville, MD, Feb. 2012).
3. EMA, Similar Biolog. Medicinal Products Contain. Biotechnoloy-derived Proteins as Active Substance (June 2006).
4. M.S. Wroblewski et al., "Emerging HealthCare Issues: Follow-on Biologic Competition," US FTC, June 11, 2009.