Looking at the recent FDA biosimilar guidelines: Immunogenicity concerns and extension to other classes of drugs

BioProcess International

Volumn 10, Issue 6, 2012, Pages 10-14

  Weinstein, Vera ^a  

^a TEVA PHARMACEUTICALS   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN; GENERIC DRUG; GLATIRAMER; PROTIRAMER; UNCLASSIFIED DRUG;

DRUG EFFICACY; DRUG INDUSTRY; DRUG MECHANISM; EOSINOPHILIA; ESTROGEN THERAPY; FIBROSIS; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; IMMUNOGENICITY; MULTIPLE SCLEROSIS; NONHUMAN; ORGAN INJURY; PATIENT SAFETY; PREDICTION; PUBLIC HEALTH SERVICE; SHORT SURVEY; UNITED STATES;

EID: 84863497602     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (9)

1. Drugs@FDA Glossary of Terms. US Food and Drug Administration: Rockville, MD, 2 February 2012; www.fda.gov/Drugs/informationondrugs/ucm079436.htm.
2. Immunogenicity of Therapeutic Biological Products, Volume 112. Brown F, Mire-Sluis AR, Eds. S Karger: Basel, Switzerland, April 2003: 3-11.
3. Implementation of the Biologics Price Competition and Innovation Act of 2009. US Food and Drug Administration: Rockville, MD, 10 March 2011; www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215089.htm.
4. CDER. Guidance for Industry: Scientific Considerations for Demonstrating Biosimilarity to a Reference Product. US Food and Drug Administration: 9 February 2012; www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.
5. Guideline on Similar Biological Medicinal Products. European Medicines Agency: London, UK, 30 October 2005; www.emea.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003517.pdf.
6. Immunogenicity of biosimilar Low Molecular Weight Heparins. Generics and Biosimilars Initiative: Mol, Belgium, 22 April 2011; www.gabionline.net/ Biosimilars/Research/Immunogenicity-of-biosimilar-lowmolecular-weight-heparins.
7. CDER. FDA Statement on Generic Premarin. US Food and Drug Administration: Rockville, MD, 25 June 2009; www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm169045. htm.
8. Data on File. Teva Neuroscience, Inc.: Petach Tikva, Israel.
9. Jahn E, Schneider C. How to Systematically Evaluate Immunogenicity of Therapeutic Proteins: Regulatory Considerations. New Biotechnol. 25(5) 2009: 280-286.