Biosimilars in Nephrology: Pfizer’s Retacrit Gets FDA Clearance and Prepares to Challenge Amgen’s Anemia Franchise Head On

Following the receipt of two Complete Response Letters from the FDA related to manufacturing issues,Pfizer‘s Retacrit was finally cleared for marketing authorization. Retacrit is the first biosimilar ESA to become available in the US.

According to Jay Wish, M.D. Professor of Clinical Medicine at Indiana University and a well-known anemia expert, “The availability of Retacrit in the US is an advance that can potentially offset costs for the healthcare system and patients. The clinical development program for Retacrit and the product’s extensive post-marketing experience in the EU demonstrate a high-quality alternative to branded ESAs which have been unchallenged since the introduction of Amgen‘s Epogen in 1999.” Wish further concludes, “To what degree Retacrit is successful will be largely dependent on adoption within the large dialysis organizations, DaVita and Fresenius, as well as Pfizer’s ability to secure a favorable position in the hospital setting, where large populations of patients with chronic kidney disease and anemia are frequently treated with ESAs. The success of Retacrit will also depend upon the degree to which prescription drug plans for patients with non-dialysis chronic kidney disease favor the drug over branded ESA alternatives for treatment of anemia.”

A survey of 202 nephrologists fielded in March 2018 suggests that the market will be largely receptive, particularly if use of Retacrit is mandated by dialysis organizations. Only 22% agree with the statement “I would not be pleased if my dialysis center switched to a biosimilar ESA”. More than being concerned about therapeutic equivalence in efficacy and safety, nephrologists do not want to be forced to switch patients that are stable on their current ESA, which could be a barrier to full facility conversions. Nephrologists are also very divided on whether it is easy to switch between long-acting ESAs (such as Amgen’s Aranesp and Roche/Vifor’s Mircera) and short-acting ESAs (such as Epogen and Retacrit), and the increased use of long-acting ESAs over the past two years in the dialysis setting may present a nephrology audience less willing to switch.

In the pre-dialysis setting, nephrologists indicate that the number one area of unmet need for a new anemia treatment is improved access and affordability for patients, making a less costly biosimilar immensely appealing. The majority of office-based nephrologists surveyed report that their practice offers on-site purchase and administration of ESAs, most commonly Johnson & Johnson’s Procrit, to which Retacrit is a biosimilar. Although the extended dosing frequency of Aranesp is largely preferred for patient convenience in this setting, the payer landscape trumps this benefit in most cases, opening a large opportunity for Retacrit.

The opportunity for Retacrit may be short-lived however, especially in the non-dialysis setting, as nephrologists eagerly anticipate the introduction of the HIF-PH inhibitors (hypoxia-inducible factor prolyl hydroxylase enzyme inhibitors, “HIFs”), including AstraZeneca/Astellas/FibroGen‘s roxadustat, Akebia/Otsuka’s vadadustat, and GSK’s daprodustat In addition to offering a convenient, patient preferred oral formulation, many nephrologists also anticipate that the HIFs will offer improved safety compared and a more physiologic approach to treating anemia compared to ESAs. Says Wish, “The HIFs have the potential to be game-changers in renal anemia and we look forward to the Phase 3 data due out later this year to confirm the clinical benefits of these agents compared to current standard of care.”

RealTime Dynamix™: Renal Anemia is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. The next wave of this study will be published in June.

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