The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents and that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent.
ASCO and ASH first published their guidelines on ESAs in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.
In producing the 2019 guideline update, ASCO and ASH reviewed randomized controlled trials and meta-analyses on ESAs used in treating patients with cancer or chronic kidney disease, as well as cohort studies in patients with cancer, focusing on literature published between 2010 and 2018. An expert panel was convened to assess the evidence and revise previous recommendations.
With respect to biosimilars, hemoglobin response and immunogenicity were outcomes of interest in addition to the primary outcomes of mortality, frequency of red blood cell transfusion, thromboembolic risk, and progression-free survival.
The new guideline includes the moderate recommendation, on the basis of intermediate-quality evidence, that epoetin beta and alfa, darbepoetin, and biosimilar epoetin alfa are all equivalent with respect to their safety and efficacy.
“Based on limited evidence, it seems that compared with the originator, biosimilars of epoetin alfa are safe and effective,” write the authors. They add that biosimilar ESAs have been used in Europe for more than a decade without major concerns having arisen.
“Ultimately, the choice of a particular agent will depend on cost, availability, convenience, and personal considerations or preference,” they write.
Reference
Bohlius J, Bohlke K, Castelli R, et al. Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. Blood Advances. 2019;3:1197-1210. doi: 10.1182/bloodadvances.2018030387.
Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan
June 17th 2025Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Biosimilars Offer New Hope for European Patients Facing High Eculizumab Costs
May 20th 2025Eculizumab biosimilars could provide European patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome better access to care for a better price, similar to successes seen in other biosimilar markets, according to a review.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.