European perspective on biosimilars

Bioanalysis

Volumn 5, Issue 5, 2013, Pages 521-524

  Wadhwa, Meenu ^a   Thorpe, Robin ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

comparability; global development; immunogenicity; reference product; reference standards; terminology; WHO

Indexed keywords

BIOSIMILAR AGENT; ERYTHROPOIETIN; GENERIC DRUG; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; RECOMBINANT ERYTHROPOIETIN;

BIOEQUIVALENCE; BIOMEDICINE; BIOTECHNOLOGY; CLINICAL STUDY; DRUG APPROVAL; DRUG EFFICACY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG STABILITY; EUROPE; HUMAN; IMMUNOGENICITY; IMMUNOLOGICAL MONITORING; PATIENT SAFETY; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; WORLD HEALTH ORGANIZATION;

BIOSIMILAR PHARMACEUTICALS; EUROPE; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; IMMUNOGENETIC PHENOMENA; REFERENCE STANDARDS; THERAPEUTIC EQUIVALENCY;

EID: 84874173298     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.2     Document Type: Review

References (18)

1. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann. Oncol. 19, 411-419 (2008). (Pubitemid 351325660)
2. Shaw BE, Confer DL, Hwang WY, Pamphilon DH, Pulsipher MA. Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: Position of the World Marrow Donor Association. Haematologica 96, 942-947 (2011).
3. Niederwieser D, Schmitz S. Biosimilar agents in oncology/haematology: from approval to practice. Eur. J. Haematol. 86, 277-288 (2011).
4. Minghetti P, Rocco P, Cilurzo F, Vecchio LD, Locatelli F. The regulatory framework of biosimilars in the European Union. Drug Discov. Today 17, 63-70 (2012).
5. Weise M, Bielsky MC, De Smet K et al. Biosimilars - why terminology matters. Nat. Biotechnol. 29, 690-693 (2011).
6. Thorpe R, Wadhwa M. Terminology for biosimilars - a confusing minefield. Generics Biosimilars Initiative J. 1(3-4), 132-134 (2012).
7. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int. 80, 88-92 (2011).
8. Nafissi S, Azimi A, Amini-Harandi A, Salami S, Shahkarami MA, Heshmat R. Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex® in relapsing remitting multiple sclerosis: A double blind randomized clinical trial. Clin. Neurol. Neurosurg. 114(7), 986-989 (2012).
9. Weise M, Bielsky MC, De Smet K et al. Biosimilars: What clinicians should know. Blood 120(26), 5111-5117 (2012).
10. Schneider CK, Borg JJ, Ehmann F et al Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). In support of the European Union biosimilar framework. Nat. Biotechnol. 30(8), 745-748 (2012).
11. Schneider CK, Vleminckx C, Gravinis I et al. Setting the stage for biosimilar monoclonal antibodies. Nat. Biotechnol. 30(12), 1179-1185 (2012).
12. Haag-Weber M, Eckhardt KU, Hörl WH et al. Safety, immunogenicity and efficacy of subcutanteousbiosimilarepoetin-a (HX575) in non-dialysis patients with renal anemia: A multi-center, randomized, double-blind study. Clin. Nephol. 77, 8-17 (2012).
13. Brockmeyer C, Seidl A. Binocrit®: Assessment of quality, safety and efficacy of biopharmaceuticals. Eur. J. Hosp. Pharm. Prac. 15(2), 34-40 (2009).
14. Skrlin A, Radic I, Vuletic M et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 38, 557-566 (2010).
15. Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat. Biotechnol. 28, 28-31 (2010).
16. Thorpe R, Wadhwa M. Intended use of reference products and WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars). Biologicals 39(5), 262-265 (2011).
17. Seidl A, Hainzl O, Richter M et al. Tungsten-induced denaturation and aggregation of epoetinalfa during primary packaging as cause of immunogenicity. Pharm. Res. 29, 1454-1467 (2012).
18. Straus, S, Giezen, TJ Pharmacovigilance of biosimilars: Challenges and possible solutions. Generics Biosimilars Initiative J. 1(3-4), 118-119 (2012).