Biosimilars – Current Treatment – Nephrology

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.


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

launch Related Market Assessment Reports