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MSL Talk: Tom Caravela, Amanda Lally
Epoetin
Biosimilars
Interchangeable
Substitution
Guidelines
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The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
Summary
- Biosimilars are biologic drug products similar to reference drugs in various attributes, including safety and efficacy.
- Biosimilar epoetin was approved by the FDA in 2018 after previous non-approval letters in 2015 and 2017 despite positive reviews by the FDA's Oncologic Drugs Advisory Committee (ODAC).
- The article discusses FDA approval processes, issues of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance.
- In the U.S., biosimilar epoetin's use in oncology is variable, influenced by policy statements from insurers like AETNA, United Health Care, and Humana, favoring biosimilar epoetin for new oncology starts unless otherwise necessary.
- There has been a significant decline in reference epoetin usage due to safety concerns, dropping to less than 5% among cancer patients with chemotherapy-induced anemia by 2012.
- Biosimilar epoetin usage between 2018 and 2020 varied: it increased to 81% among some Medicare patients, 41% among commercial insurance patients, and reached 100% in a California county hospital, while some Veterans Administration Hospitals reported 0% usage.
- Pricing and safety are significant factors affecting the uptake of biosimilar epoetin in oncology.
- There is a lack of understanding among oncologists about the substitution and interchangeability of biosimilars with reference drugs, and the concept of epoetin biosimilars is relatively new to both physicians and patients.
Biosimilar drugs, close copies of patented biologicals, are intended to provide access to less expensive, highly similar versions of approved reference biological agents. The biological epoetin accounts for $1.8 billion in drug spending annually worldwide, primarily for treatment of anemia due to chronic kidney disease or cancer chemotherapy.
Mature epoetin biosimilar markets have existed in European Union (EU) countries since 2007, as five epoetin biosimilar formulations have received regulatory authorizations in EU countries . Biosimilar epoetins account for 45% of EU epoetin sales (varying by country). Similarly, oncology biosimilar uptake in the U.S. for filgrastim was rapid, accounting for 52% market share at 18 months. Herein, we review the development of the first epoetin biosimilar in the U.S. and compare its use with that of biosimilar epoetins in Europe and biosimilar filgrastim in the U.S.
Epoetin, Biosimilars, Interchangeable, Substitution, Guidelines
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