References
- Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.
- Kozlowski S, Woodcock J, Midthun K, et al. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385–388.
• First description of the sience of biosimilar development within the regulatory framework required by the BPCI Act.
- Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Silver Spring (MD): U.S. Food and Drug Administration; 2014 May 13.
•• Regulatory guidline which describes the clinical studies needed to support the demonstration of biosimilarity.
- Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Silver Spring (MD): U.S. Food and Drug Administration; 2015 Apr 28.
•• Regulatory guidline which gives an overview of the FDA’s scientific approach to determine biosimilarity. Describes the totality of evidence concept.
- Food and Drug Administration. Quality considerations in demonstrating biosimilarity to a reference protein product. Silver Spring (MD): U.S. Food and Drug Administration; 2015 Apr 28.
•• Regulatory guidline which describes in great detail which quality factors should be taken into account when analytically characterizing the biosimilar product.
- Food and Drug Administration. Zarxio (filgrastim-sndz) drug approval review documents. 2005 [cited 2015 Nov 14]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm.
• Publicly available document which describes the FDA’s biosimilarity assessment of filgrastim-sndz.
- January 7 2015 Oncology Drugs Advisory Committee Meeting. 2015 [cited 2015 Nov 14]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm426351.htm.
• First Advisory Committee Meeting on a biosimilar.
- Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29(4):310–312.
- CHMP assessment report by the Europeam Medicines Agency for Zarzio. 2008 [cited 2015 Nov 14]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000917/WC500046528.pdf
- Blackwell K, Semiglazov V, Krasnozhon D, et al. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015;26(9):1948–1953.
• Publication which describes the confirmatory clinical trial in breast cancer patients.
- Sörgel F, Schwebig A, Holzmann J, et al. Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics. BioDrugs. 2015;29(2):123–131.
- European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). London: European Medicines Agency; 2012.
- Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72(3):315–318.
• Discusses the subject of manufacturing process changes after approval for mAbs and fusion proteins authorised in rheumatological indications.
- Aapro M, Cornes P, Abraham I. Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. J Oncol Pharm Pract. 2012;18(2):171–179.