Delivering on the Promise of Biosimilars
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Fifteen years of experience with biosimilar evaluation in Europe and advancement in the science behind biological medicines, provides a timely moment to open up debate as to whether the requirements for biosimilar approval could be further tailored. Further optimizing of data requirements to truly decisional information will allow to continuously deliver on the promise of biosimilars, providing benefits for patients and society.
AGV would like to thank Liese Barbier (MSc Pharmacy; PhD researcher, KU Leuven) for the stimulating discussions and Michelle Derbyshire (www.MD-writing.eu) for linguistic review.
Compliance with Ethical Standards
No funding relevant to this commentary was received.
Conflict of interest
AGV is one of the founders of the Research Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL Fund) and is involved in consulting, advisory work and speaking engagements for a number of companies, i.e. AbbVie, Accord, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Novartis, Sandoz, and Boehringer Ingelheim.
- 1.IQVIA. The impact of biosimilar competition in Europe. Quintiles IMS. 2018;2018:33.Google Scholar
- 2.IMS. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets introduction. IMS Inst Healthc Informatics. 2016;2016:40.Google Scholar
- 4.European Medicines Agency. Biosimilar medicines. 2019. https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine/field_ema_med_status/authorised-36/ema_medicine_types/field_ema_med_biosimilar/search_api_aggregation_ema_medicine_types/field_ema_med_biosim. Accessed 9 Sep 2019.
- 5.Harston A. FDA’s biosimilar approvals accelerate in 2018: how the US compares to Europe on biosimilar approvals and products in the pipeline. 2019. https://www.biosimilarsip.com/2019/02/05/fdas-biosimilar-approvals-accelerate-in-2018-how-the-u-s-compares-to-europe-on-biosimilar-approvals-and-products-in-the-pipeline/. Accessed 13 Sep 2019.
- 6.European Medicines Agency. ICH Topic Q5 E Comparability of biotechnological/biological products. 2005.Google Scholar
- 10.Eric Sagonowsky. AbbVie’s massive Humira discounts are stifling Netherlands biosimilars: report|FiercePharma. 2019.https://www.fiercepharma.com/pharma/abbvie-stifling-humira-biosim-competition-massive-discounting-dutch-report. Accessed 13 Sep 2019.
- 11.Sy Mukherjee. Protect at all costs: how the maker of the world’s bestselling drug keeps prices sky-high. Fortune. 2019.https://fortune.com/longform/abbvie-humira-drug-costs-innovation/. Accessed 13 Sep 2019.