Biosimilars of erythropoiesis-stimulating agents (ESAs) entered the European market a decade ago, but the FDA did not approve the first ESA biosimilar—Retacrit—until June 2018; it launched in the United States in November 2018. Despite the availability of multiple ESA biosimilars for chronic kidney disease (CKD) for several years, their uptake in Europe has varied from country to country, as well as by drug and manufacturer. With new biosimilars expected to soon enter all three markets under study (United States, France, and Germany), it is vital to understand why ESA biosimilar uptake varies in Europe and the likely impact of upcoming biosimilar launches in the United States and Europe. We surveyed nephrologists from France, Germany, and the United States to learn about their experience and familiarity with current biosimilars, the drivers of and barriers to these agents’ uptake, nephrologists’ interest in prescribing biosimilars in the future, and their expectations for novel biosimilars.
Scope:
Markets covered: United States, France, and Germany.
Primary research: Online quantitative survey of 91 nephrologists.
Questions answered:
- What is the current patient share of CKD biosimilars, and what expectations do nephrologists have for future patient shares?
- How similar do nephrologists believe biosimilars are to their reference brands?
- What factors do nephrologists identify as being the key drivers of and barriers to biosimilar uptake?
- How will the entrance of biosimilar versions of the following change the total volume (i.e., brands + biosimilars) of that drug prescribed in the predialysis and dialysis settings
- What percentage of biosimilar-treated patients were initiated on a biosimilar, and what percentage were switched from a reference brand?
- How long after launch do you expect it to take for 50% of your CKD patients on the following ESA brand(s) to receive a biosimilar version (by switching, increasing use of biosimilars in newly treated patients, or both) that costs 30% less than the brand?
Key companies mentioned:
- Amgen
- Janssen
- Johnson & Johnson
- Medice Arzneimittel Putter
- Pfizer
- Roche
- Sandoz (Novartis)
- Stada Arzneimittel
- Vifor Pharma
Key drugs mentioned:
- Abseamed
- Aranesp
- Binocrit
- Epoetin Alfa Hexal
- Epogen
- Eprex/Erypro
- Mircera
- NeoRecormon
- Procrit
- Retacrit
- Silapo
Sunayna Joshi
Sunayna Joshi, B.Pharma., is an associate analyst on the Biosimilars team at Clarivate. Prior to joining the company, she worked as an associate at Prescient Health Care Group and as a knowledge management analyst at ZS Associates. She is experienced in pharmaceutical competitive analysis, clinical trial analysis, and market research. Ms. Joshi graduated from the Acropolis Institute of Technology in Indore, India, with a bachelor’s degree in pharmacy.
Hamzah Aideed, M.Sc.
Hamzah Aideed, M.Sc., is a manager on the Biosimilars team at Clarivate. His team conducts both primary and secondary market research to provide in-depth analysis and key insights into biosimilars and the biopharmaceutical industry. Previously, Mr. Aideed was a senior research executive in consulting at McCann Health, specializing in the design and execution of advanced qualitative and quantitative research methodologies for bespoke ad-hoc consulting projects. He holds an M.Sc. in biotechnology, bioprocessing, and business management from the University of Warwick and a B.Sc. in biological chemistry from Aston University in Birmingham.