Publications and Thought Leadership: Biosimilars, Biobetters & Bioparallels

JOURNALS

ECONOMICS, POLICY & REGULATORY

Abraham I, MacDonald K. Biosimilars, biobetters, and bioparallels: the evolving landscape of biologics. JAMA Dermatology (2025, in press).

Abraham I, Beddor AN, MacDonald M. The clinical and economic value of follow-on biologics: biosimilars, biobetters, and bioparallels. British Journal of Hospital Medicine (2025, in press).

Abraham I, Calamia M, Alkhatib N, Pondel M, MacDonald K. Budget impact analysis of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer. Journal of Medical Economics 2024;27(Sup3):36-50.

MacDonald K, Pondel M, Abraham I. Cost-efficiency and budget-neutral expanded access modeling of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell cancer. Journal of Medical Economics 2024;27(Suppl.3):24-33.

Abraham I, Calamia M, Alkhatib NS, Pondel M, MacDonald K. Budget impact analysis of the novel PD-1 inhibitor toripalimab versus pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Journal of Medical Economics 2024;27(Suppl.3):9-23.

MacDonald K, Pondel, Abraham I. Cost-efficiency and budget-neutral expanded access modeling of the novel PD-1 inhibitor toripalimab versus pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Journal of Medical Economics 2024;27(Suppl.3):1-8.

Abraham I, Crawford J, Schwartzberg L. On-body injector pegfilgrastim for chemotherapy-induced neutropenia prophylaxis: current status. Cancer Treatment and Research Communications 2024;40:100824.

Abraham I. Preparing for the third decade of biosimilars. Expert Opinion on Biological Therapy 2023;23:651-652.

Calamia M, Abraham I. The economics of biosimilars: addressing unmet medical needs in low- and middle-income countries. Expert Opinion on Biological Therapy 2023;23:653-657.

Alkhatib N, Halloush S, Abraham I. The status and preparation for the next decade of biosimilars in the Middle Eastern and North African region. Expert Opinion on Biological Therapy 2023;23:671-677.

Halawa H, Alkhatib N, Almutairi A, Salah M, Halloush S, Rashdan O, Masadh L, Abu Sarah O, Abraham I. Economic modeling for Jordan of the cost-efficiency and associated expanded treatment access of conversion to rituximab biosimilar from reference rituximab. Journal of Medical Economics 2023;26:835-842.

Yousef CC, Khan MA, Almodaimegh H, Alshamrani M, Alfoheidy MO, AlAbdalkarim H,  AlJedai A, Naeem A,  Abraham I. Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study. Journal of Medical Economics 2023;26:394-402.

McBride A, Alrawashdh N, MacDonald K, Abraham I. Expanded access to anticancer treatments from conversion to biosimilar pegfilgrastim-cbqv in US breast cancer patients. Future Oncology 2022;18:363-373.

MacDonald K, Alrawashdh N, McBride A, Abraham I. Conversion to biosimilar pegfilgrastim-cbqv enables budget-neutral expanded access to FOLFIRINOX treatment for metastatic pancreatic cancer. Future Oncology 2021;17:4561-4570.

McBride A, MacDonald K, Fuentes-Alburo A, Abraham I. Cost-efficiency and expanded access modeling of conversion to biosimilar trastuzumab-dkst with or without pertuzumab in metastatic breast cancer. Journal of Medical Economics 2021;24:743-756.

McBride A, MacDonald K, Fuentes-Alburo A, Abraham I. Conversion from pegfilgrastim with on-body injector to biosimilar pegfilgrastim-jmdb: cost-efficiency analysis and budget neutral access to prophylaxis and treatment. Journal of Medical Economics 2021;24:598-606.

McBride A, MacDonald K, Abraham I. Conversion to supportive care with biosimilar pegfilgrastim-cbqv enables budget-neutral expanded access to R-CHOP treatment in non-Hodgkin lymphoma. Leukemia Research 2021;106:106591.

MacDonald K, McBride A, Abraham I. Cost-efficiency and expanded access of prophylaxis for chemotherapy-induced (febrile) neutropenia: economic simulation analysis for the US of conversion from reference pegfilgrastim to biosimilar pegfilgrastim-cbqv. Journal of Medical Economics 2020; 23:1466-1476.

McBride A, Wang W, Campbell K, Balu S, MacDonald K, Abraham I. Economic modeling for the US of the cost-efficiency and associated expanded treatment access of conversion to biosimilar pegfilgrastim-bmez from reference pegfilgrastim. Journal of Medical Economics 2020;23(8):856-863.

McBride A, Krendyukov A, Mathieson N, Campbell K, Balu S, Natek M, MacDonald K, Abraham I. Febrile neutropenia hospitalization due to pegfilgrastim on-body injector failure compared to single-injection pegfilgrastim and daily injections with reference and biosimilar filgrastim: US cost simulation for lung cancer and non-Hodgkin lymphoma. Journal of Medical Economics 2020;23(1):28-36.

McBride A, Campbell K, Bikkina M, MacDonald K, Abraham I, Balu S. Reply: Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of Medical Economics 2018;21:606-609.

McBride A, Campbell K, Bikkina M, MacDonald K, Abraham I, Balu S. Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia. Journal of Medical Economics 2017;20:1083-1093.

McBride A, Balu S, Campbell K, Bikkina M, MacDonald K, Abraham I. Expanded access to cancer treatments from conversion to neutropenia prophylaxis with biosimilar filgrastim-sndz. Future Oncology 2017;13:2285-2295.

Covic A, Abraham I. State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. International Urology and Nephrology 2015;47:1529-1539.

Sun D, Andayani TM, Altyar A, MacDonald K, Abraham I. Potential cost savings from chemotherapy-induced febrile neutropenia prophylaxis with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European G5 countries: a simulation study. Clinical Therapeutics 2015;37:842-857.

Abraham I, Han L, Sun D, MacDonald K, Aapro M. Cost savings from anemia management with biosimilar epoetin α and increased access to targeted antineoplastic treatment: simulation for the European G5 countries. Future Oncology 2014;10:1599-1609.

Aapro M, Cornes P, Sun D, Abraham I. Comparative cost-efficiency across the European Union G5 countries of originators and a biosimilar erythropoiesis-stimulating agent to manage chemotherapy-induced anemia in cancer patients. Therapeutic Advances in Medical Oncology 2012;4:95-105.

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. Journal of Oncology Pharmacy Practice 2012;18:171-179.

CLINICAL EFFECTIVENESS & SAFETY

McBride A, AlRawashdh N, Bartels T, Moore L, Persky D, Abraham I. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy. Future Oncology 2021;17:3485-3497.

Ludwig H, Gascón P, Bokemeyer C, Aapro M, Boccadoro M, Denhaerynck K,  Krendyukov A, MacDonald K, Abraham I. Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated “same-day” (<24 hours), “per-guidelines” (24-72 hours), and “late” (>72 hours): findings from the MONITOR-GCSF study. Supportive Care in Cancer 2019;27:2301-2312.

Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I , MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrology 2019;20:81.

Ludwig H, Bokemeyer C, Aapro M, Boccadoro M, Gascón P, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in solid tumours versus haematological malignancies: patterns, outcomes and determinants (MONITOR-GCSF study). Future Oncology 2019;15:897-907.

London G, Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, Denhaerynck K, Hoebel N, Krendyukov A, MacDonald K, Abraham I. Long-term treatment with biosimilar epoetin-a (HX575) in haemodialysis patients with renal anaemia: real-world effectiveness and safety in the MONITOR-CKD5 study. Clinical Nephrology 2018;89(1):1-9.

Bokemeyer C, Gascón P, Aapro M, Ludwig H, Boccadoro M, Denhaerynck K, Gorray M, Krendyukov A, Abraham I, MacDonald K. Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study. Supportive Care in Cancer 2017;25:1819-1828.

Aapro M, Bokemeyer C, Ludwig H, Gascón P, Boccadoro M, Denhaerynck K, Gorray M, Krendyukov A, MacDonald K, Abraham I. Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in elderly versus non-elderly cancer patients: patterns, outcomes, and determinants (MONITOR-GCSF study). Journal of Geriatric Oncology 2017;8:86-95.

Aapro M, Ludwig H, Bokemeyer C, Gascón P, Boccadoro M, Denhaerynck K, Krendyukov A, Gorray M, MacDonald K, Abraham I. Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study). Annals of Oncology 2016;27:2039-2045.

Gascón P, Aapro M, Ludwig H, Bokemeyer C, Boccadoro M, Turner M, Denhaerynck K, MacDonald K, Abraham I. Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (the MONITOR-GCSF study). Supportive Care in Cancer 2016;24:911-925 (Erratum published: Supportive Care in Cancer 2016;24:927).

Gesualdo L, Combe C, Covic A, Dellanna F, Goldsmith D, London G, Mann J, Zaoui P, Turner M, Muenzberg M, MacDonald K, Abraham I. Risk-based individualisation of target haemoglobin in haemodialysis patients with renal anaemia in the post-TREAT era: theoretical attitudes versus actual practice patterns (MONITOR-CKD5 study). International Urology and Nephrology 2015;47:837-845.

Tharmarajah S, Mohammed A, Bagalagel A, MacDonald K, Abraham I. Clinical efficacy and safety of Zarzio (EP2006), a biosimilar recombinant human granulocyte colony stimulating factor. Biosimilars 2014;4:1-9.

Bagalagel A, Mohammed A, MacDonald K, Abraham I. Clinical efficacy and safety of Tevagrastim® (XM02), a biosimilar recombinant human granulocyte colony stimulating factor. Biosimilars 2013;3:55-62.

Mohammed A, Bagalagel A, MacDonald K, Abraham I. Clinical efficacy and safety of XM01, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars 2013;3:45-53.

Bagalagel A, Mohammed A, MacDonald K, Abraham I. Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars 2013;3:35-43.

Gesualdo L, London G, Turner M, Lee C, MacDonald K, Covic A, Zaoui P, Combe C, Dellana F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine 2013;8:389-399.

Abraham I, Sun D, Bagalagel A, Altyar M, Mohammed A, Tharmarajah S, MacDonald K. Biosimilars in 3D: definition, development, and differentiation. BioEngineered 2013;4:203-206.

Abraham I, Tharmarajah S, MacDonald K. Clinical safety of biosimilar recombinant human granulocyte colony stimulating factors. Expert Opinion on Drug Safety 2013;12:235-246.

Abraham I, MacDonald K. Clinical safety of biosimilar recombinant human erythropoietins. Expert Opinion on Drug Safety 2012;11:819-840.

Abraham I, MacDonald K. Clinical efficacy and safety of HX575, a biosimilar recombinant human erythropoietin, in the management of anemia. Biosimilars 2012;2:13-25.

Gascón P, Aapro M, Ludwig H, Rosencher N, Boccadoro M, Turner M, MacDonald K, Muenzberg M, Abraham I. Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments. Critical Reviews in Oncology and Hematology 2011;77:198-200.

Gascón P, Aapro M, Ludwig H, Rosencher N, Turner M, Song M, MacDonald K, Lee C, Muenzberg M, Abraham I. Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim. Critical Reviews in Oncology and Hematology 2011;77:184-197.

BOOKS, JOURNAL ISSUES & MONOGRAPHS

Abraham I, MacDonald K (Guest editors). Economic evaluations of the novel PD-1 inhibitor toripalimab (Journal of Medical Economics). London, UK: Taylor & Francis, in process.

Abraham I (Guest editor). Preparing for the third decade of biosimilars (Expert Opinion on Biological Therapy). London, UK: Taylor & Francis, 2023.

Abraham I (Consulting editor). The managed healthcare market (8th ed.). Roanoke, VA: CMR Institute, 2021.

Abraham I (Consulting Editor). The entry of biosimilars in the US market. Roanoke, VA: CMR Institute, 2021.

Abraham I (Consulting Editor). Protecting market access as biosimilars emerge. VA: CMR Institute, 2021.

Abraham I (Consulting editor). The managed healthcare market (7th ed.).  Roanoke, VA: CMR Institute, 2019.

Abraham I (Consulting editor). The managed healthcare market (6th ed.). Roanoke, VA: CMR Institute, 2016.

COLUMNS

Abraham I. Not all quiet on the biologics front: biosimilars, biobetters, and bioparallels. Center for Biosimilars (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-not-all-quiet-on-the-biologics-front-biosimilars-biobetters-and-bioparallels

Abraham I. The 2022 WHO guidelines on biosimilars: loosening the reins or changing the track? Part 2. Center for Biosimilars (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-the-2022-who-biosimilar-guidelines-loosening-the-reins-or-changing-the-track-part-2

Abraham I. The 2022 WHO guidelines on biosimilars: loosening the reins or changing the track? Part 1. Center for Biosimilars (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-the-2022-who-biosimilar-guidelines-loosening-the-reins-or-changing-the-track-part-1

Abraham I. Biologics and biosimilars: harnessing regulatory data for value, access, equity and parity. Center for Biosimilars (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-biologics-and-biosimilars-harnessing-regulatory-data-for-value-access.

Abraham I. 1 billion people can access biosimilars; what about the other 7 billion? Center for Biosimilars 2022 (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-1-billion-people-can-access-biosimilars-what-about-the-other-7-billion-

Abraham I. Biosimilars and the commoditization of treatments. Center for Biosimilars 2022 (column). https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-biosimilars-and-the-commoditization-of-treatments

Abraham I. It’s what we do with the savings: economics and equity. Center for Biosimilars 2022. (column) https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-it-s-what-we-do-with-the-savings-economics-and-equity

Abraham I. Good bait and fair switch: biosimilar interchangeability, substitution, and choice. Center for Biosimilars 2022. (column) https://www.centerforbiosimilars.com/view/contributor-good-bait-and-fair-switch-biosimilar-interchangeability-substitution-and-choice

Abraham I. To try or not to try, that’s not the question: phase 3 trials of biosimilars and beyond. Center for Biosimilars 2022. (column) https://www.centerforbiosimilars.com/view/contributor-to-try-or-not-to-try-that-s-not-the-question-phase-3-trials-of-biosimilars-and-beyond

Abraham I. The enemy of your enemy should be your friend: why biosimilar companies should collaborate. Center for Biosimilars 2022. (column) https://www.centerforbiosimilars.com/view/contributor-the-enemy-of-your-enemy-should-be-your-friend-why-biosimilars-companies-should-collaborate

MEDIA

Abraham I. The role of risk sharing models in biosimilar adoption. Center for Biosimilars 2024

Abraham I. Promoting informed decision-making through biosimilar awareness. Center for Biosimilars 2024

Abraham I. Strategies for effective biosimilar education, adoption. Center for Biosimilars 2024

Abraham I. Bridging clinical practice, health economics for improved patient access. Center for Biosimilars 2024

Abraham I. Streamlining biosimilar approvals by balancing safety, speed. Center for Biosimilars 2024

Abraham I. The pandemic’s effect on biosimilar utilization. Center for Biosimilars 2021

Abraham I. Biosimilar pegfilgrastims vs Neulasta Onpro utilization. Center for Biosimilars 2021

Abraham I. How Neulasta Onpro is impacting the biosimilars space. Center for Biosimilars 2021

Abraham I. The current state of G-CSF biosimilars in the US. Center for Biosimilars 2021

Abraham I. The pandemic’s effect on pegfilgrastim biosimilar use (part 2). Center for Biosimilars 2021

Abraham I. Biosimilar pegfilgrastim savings amid COVID-19 (part 1). Center for Biosimilars 2020

Abraham I. Biosimilars in the United States: where we’ve been and where we’re headed. Center for Biosimilars 2019

Abraham I. Key features of a biosimilar. OBROncology, ASCO 2018

Abraham I. Biosimilars approved or close to approval. OBROncology, ASCO 2018

Abraham I. Hurdles that could prevent the adoption of biosimilars. OBROncology, ASCO 2018

Abraham I. How to demonstrate the value of cancer treatments. OBR Oncology, ASCO 2018

Abraham I. Biosimilar pricing and reimbursement. OBR Oncology, ASCO 2018

Disclosure: The publications listed here blend articles reporting on studies and projects contracted to MATRIX45 and predecessor companies, independent projects initiated by MATRIX45, as well as academic projects by Ivo Abraham’s academic research groups.

Hyperlinks to publications are being added