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Discover more materials to enhance your attitude, skills and knowledge on biosimilar use within oncology
A selection of evidence-based and peer-reviewed literature to expand your learnings on biosimilars and increase your confidence of their use in clinical practice
Emerging trends in biosimilar development as seen through the EU regulatory network may improve patient access
Article title: The EU regulatory network and emerging trends – a review of quality, safety, and clinical development programmes
Citation: Zuccarelli M et al. GaBI J 2021;10:83–99
Publication date: March 2021
Biosimilars are set to become integral to cancer therapy
Article title: Are Biosimilars the Future of Oncology and Haematology?
Citation: Zinzani PL et al. Drugs 2019;79:1609–24
Publication date: October 2019
Pegfilgrastim biosimilar MYL-1401H exerts equivalent efficacy to reference product in preventing chemotherapy-induced neutropenia in patients with breast cancer
Article title: Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia
Citation: Waller CF et al. Ann Hematol 2019;98:1217–24
Publication date: May 2019
MYL-0140 is bioequivalent to both EU-trastuzumab and US-trastuzumab in healthy subjects
Article title: A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O vs. EU‐trastuzumab and US‐trastuzumab
Citation: Waller CF et al. Br J Clin Pharmacol 2018;84:2336–43
Publication date: October 2018
Equivalence study to compare the effects of ABP 980 biosimilar versus reference trastuzumab shows similar pathologic response rates in women with HER2-positive early breast cancer in neoadjuvant setting
Article title: Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial
Citation: von Minckwitz G et al. Lancet Oncol 2018;19:987–98
Publication date: July 2018
Recent approval of several trastuzumab biosimilars provide an example of how a robust clinical development program works in practice
Article title: The rise of oncology biosimilars: from process to promise
Citation: Verrill M et al. Future Oncol 2019;15:3255–65
Publication date: October 2019
The phase III, randomised MAPLE study confirms biosimilarity between ABP 215 and bevacizumab RP in patients with NSCLC
Article title: Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non–small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study
Citation: Thatcher N et al. Clin Cancer Res 2019;25:2088–95
Publication date: April 2019
In the approval process for licensed biosimilars, bevacizumab paves the way for extrapolation of indications
Article title: Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer
Citation: Taïeb J et al. Clin Colorectal Cancer 2021;20:42–51
Publication date: March 2021
Understanding the role of comparative clinical studies in biosimilars evaluation and approval
Article title: Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars
Citation: Stebbing J et al. J Clin Oncol 2020;38:1070–80
Publication date: February 2020
This confirmatory efficacy and safety study was performed as the final step in assessing bioequivalence of a proposed trastuzumab biosimilar, Mylan®.
Article title: Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial
Citation: Rugo HS et al. JAMA 2017;317:37–47
Publication date: January 2017
Comparative PK/PD study in healthy subjects demonstrates biosimilarity between pegfilgrastim biosimilar Pelmeg® and Neulasta®
Article title: Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Pelmeg®, a pegfilgrastim biosimilar in healthy subjects
Citation: Roth K et al. Pharmacol Res Perspect 2019;7:e00503
Publication date: August 2019
Bevacizumab biosimilar for metastatic colorectal cancer successfully tried in Iranian phase III study
Article title: Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial
Citation: Rezvani H et al. Clin Ther 2020;42:848–59
Publication date: April 2020
International multicentre clinical trial confirms efficacy and safety of proposed biosimilar BCD-020 in comparison with reference rituximab in indolent lymphoma patients
Article title: Proposed rituximab biosimilar BCD-020 versus reference rituximab for treatment of patients with indolent non-Hodgkin lymphomas: An international multicenter randomized trial
Citation: Poddubnaya IV et al. Hematol Oncol 2020;38:67–73
Publication date: November 2019
Real-world analysis of treatment patterns for NHL and CLL in Germany reveals high acceptance of rituximab biosimilar use during first 24 months post-approval
Article title: Real-world use and acceptance of rituximab biosimilars in non-Hodgkin lymphoma in an oncologist network in Germany
Citation: Otremba B et al. Future Oncol 2020;16:1001–12
Publication date: April 2020
A study establishing that the therapeutic equivalence of rituximab biosimilar could lead to annual savings of €150 million and provide access for an additional 12,000 patients with B-cell lymphoma
Article title: Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial
Citation: Ogura M et al. Lancet Haematol. 2018;5;e543-e553
Publication date: November 2018
Biosimilars hold the potential to lower costs associated with stem cell transplant in oncology and haematology-related care
Article title: Worldwide Network for Blood and Marrow Transplantation (WBMT) perspective: the role of biosimilars in hematopoietic cell transplant: current opportunities and challenges in low- and lower-middle income countries
Citation: Muhsen IN et al. Bone Marrow Transplant 2020;55:698–707
Publication date: September 2019
In the last few years, five new biosimilar versions of trastuzumab (Herceptin) have been rigorously tested and approved by the FDA.
Article title: Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States
Citation: Miller EM & Schwartzberg LS. Ther Adv Med Oncol 2019;11:1–9
Publication date: November 2019
Lower-cost biosimilar achieves treatment targets in cancer patients experiencing anaemia due to cytotoxic chemotherapy
Article title: BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study
Citation: Michallet M et al. BMC Cancer 2014;14:1503
Publication date: July 2014
Current and future roles for biosimilars in oncology – evidence from 10 years’ experience in Europe and the USA
Article title: Current and future roles of biosimilars in oncology practice
Citation: Konstantinidou S et al. Oncol Lett 2020;19:45–51
Publication date: January 2020
Trastuzumab biosimilar ABP 980 provides an additional treatment option for patients with breast and gastric cancer
Article title: Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab
Citation: Kolberg H-C et al. Target Oncol 2019;14:647–56
Publication date: October 2019
Healthcare professionals’ trust in biosimilars is key to ensuring their availability
Article title: A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
Citation: Garcia JJ et al. Transl Lung Cancer Res 2020;9:2113–9
Publication date: October 2020
Biosimilar trastuzumab cuts an expensive obstacle to effective treatment for many women with HER2+ breast cancer
Article title: Clinical development of CT-P6 in HER2 positive breast cancer
Citation: Fu C et al. Expert Opin Biol Ther 2019:19(10);987-992
Publication date: September 2019
Houston comprehensive cancer centre develops a standardised approach to evaluate and implement biosimilar products
Article title: Navigating uncharted waters: Developing a standardized approach for evaluating and implementing biosimilar products at a comprehensive cancer center
Citation: Villanueva MN et al. Am J Health Syst Pharm 2021;78:249–60
Publication date: December 2020
Trastuzumab biosimilar ABP 980 is as safe as reference product in terms of cardiac toxicity in patients enrolled in the long-term LILAC study
Article Title: Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study
Citation: Kolberg H-C et al. Drug Safety 2020;43:233–42
Publication date: January 2020
Bioequivalence confirmed in the first population PK analysis for a bevacizumab biosimilar based on a comparative clinical study in patients with cancer
Article title: Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer
Citation: Li CSW et al. Cancer Chemother Pharmacol 2020;85:487–99
Publication date: November 2019
Improving supportive care: lessons we can learn from the introduction of biosimilars into general healthcare
Article title: Biosimilars in supportive care
Citation: Foreman E. Curr Opin Oncol 2020;32:282–8. doi: 10.1097/CCO.0000000000000631
Publication date: July 2020
Greater understanding of biosimilars among healthcare providers is key to driving their uptake
Article title: Pharmacist perspectives and considerations for implementation of therapeutic oncology biosimilars in practice
Citation: Cuellar S et al. Am J Health Syst Pharm 2019;76:1725–38
Publication date: October 2019
Comparison of regulatory, quality and clinical aspects of available LMWH biosimilars may be helpful for their selection and uptake
Article title: Biosimilars of low molecular weight heparins: Relevant background information for your drug formulary
Citation: Brouwers JRBJ et al. Br J Clin Pharmacol 2019;85:2479–86. doi: 10.1111/bcp.2021.14081
Publication date: August 2019
In rapidly changing markets, how best to illustrate interchangeability of biosimilars?
Article title: Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?
Citation: Alvarez DF et al. BioDrugs 2020;34:723–32
Publication date: September 2020
Latest Policy Review calls for more effective launch of biosimilars
Article title: Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions
Citation: Bennett CL et al. Lancet Oncol 2020;21:e575–88
Publication date: December 2020
Concise summaries of the key guidance for biosimilar use across the world, available to download and share with your multidisciplinary team
EU national regulatory agency guidance summary document
Japanese national regulatory agency guidance summary document
Canadian national regulatory agency guidance summary document
UK national regulatory agency guidance summary document
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