New Biosimilar Approvals for Myeloid Growth Factors and Anemia

US Department of Health and Human Services, Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed April 10, 2019.

US Department of Health and Human Services, Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed April 10, 2019.)| false
• Search Google Scholar
• Export Citation

Sörgel F, Schwebig A, Holzmann J, et al. Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics. BioDrugs 2015;29:123–131.

• Crossref
• PubMed
Sörgel F, Schwebig A, Holzmann J, Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics. BioDrugs 2015;29:123–131.2583783910.1007/s40259-015-0124-7)| false
• Search Google Scholar
• Export Citation

Blackwell K, Semiglazov V, Jrasbizgib 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;26:1948–1953.

• Crossref
• PubMed
Blackwell K, Semiglazov V, Jrasbizgib D, 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;26:1948–1953.2612272610.1093/annonc/mdv281)| false
• Search Google Scholar
• Export Citation

Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 2014;28;363–372.

• Crossref
• PubMed
Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 2014;28;363–372.10.1007/s40259-014-0088-z24567263)| false
• Search Google Scholar
• Export Citation

Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol 2018;36:1260–1265.

• Crossref
Lyman GH, Balaban E, Diaz M, American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol 2018;36:1260–1265.10.1200/JCO.2017.77.4893)| false
• Search Google Scholar
• Export Citation

Kozlowski S, Birger N, Brereton S, et al. Update of the biologic filgrastim and its biosimilar product among the Medicare population. JAMA 2018:320;929–931.

• Crossref
Kozlowski S, Birger N, Brereton S, Update of the biologic filgrastim and its biosimilar product among the Medicare population. JAMA 2018:320;929–931.10.1001/jama.2018.9014)| false
• Search Google Scholar
• Export Citation