Competitive Pricing Between FDA-Approved Biosimilars and Patent Drugs
Author(s)
Anwesha Kandhare, M. Pharm, Somasundaram S, Phram. D, Santosh Kumar, MA.
SIRO Clinpharm, Mumbai, India.
SIRO Clinpharm, Mumbai, India.
OBJECTIVES: Our research objective was to examine the differential Average selling price (ASP) and Wholesale acquisition cost (WAC) of a patent product against a biologic product approved by the US Food and Drug Administration (FDA) between 2024 and 2025.
METHODS: From 2024 onward, the FDA has approved a total of 24 biosimilar drugs based on reference products for the following medicines: tocilizumab, trastuzumab, adalimumab, filgrastim, aflibercept, insulin aspart, eculizumab, omalizumab, denosumab, and ustekinumab. All the names of patent products and biosimilar medications that are associated with them have been compiled. According to the Healthcare Common Procedure Coding System (HCPCS) Unit WAC Price and Medicare Part B Drug Average Sales Price databases, the ASP and WAC costs of each product were evaluated. ASP and WAC were compared between the biosimilar product and its corresponding patent product.
RESULTS: In the research, it was noted that patent drugs for immunology have 65% higher WAC costs compared to their corresponding biologics. In a similar pattern ophthalmology and endocrinology patent drugs are 45% and 95% higher WAC than that of their biosimilar counterparts, respectively. Additionally, the ASP price of biosimilar products in ophthalmology, immunology, and endocrinology is approximately 40 to 45% lower than the WAC price of biosimilar drugs.
CONCLUSIONS: It is anticipated that biosimilar products with low WAC and ASP will provide significant benefits to patients, including enhanced access for increased access to life-prolonging treatments, reduced healthcare costs, and out-of-pocket expenses, and particularly become more beneficial for those who have the co-insurance tied to the manufacturer list price.
METHODS: From 2024 onward, the FDA has approved a total of 24 biosimilar drugs based on reference products for the following medicines: tocilizumab, trastuzumab, adalimumab, filgrastim, aflibercept, insulin aspart, eculizumab, omalizumab, denosumab, and ustekinumab. All the names of patent products and biosimilar medications that are associated with them have been compiled. According to the Healthcare Common Procedure Coding System (HCPCS) Unit WAC Price and Medicare Part B Drug Average Sales Price databases, the ASP and WAC costs of each product were evaluated. ASP and WAC were compared between the biosimilar product and its corresponding patent product.
RESULTS: In the research, it was noted that patent drugs for immunology have 65% higher WAC costs compared to their corresponding biologics. In a similar pattern ophthalmology and endocrinology patent drugs are 45% and 95% higher WAC than that of their biosimilar counterparts, respectively. Additionally, the ASP price of biosimilar products in ophthalmology, immunology, and endocrinology is approximately 40 to 45% lower than the WAC price of biosimilar drugs.
CONCLUSIONS: It is anticipated that biosimilar products with low WAC and ASP will provide significant benefits to patients, including enhanced access for increased access to life-prolonging treatments, reduced healthcare costs, and out-of-pocket expenses, and particularly become more beneficial for those who have the co-insurance tied to the manufacturer list price.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD42
Topic
Economic Evaluation, Health Policy & Regulatory, Real World Data & Information Systems
Topic Subcategory
Distributed Data & Research Networks
Disease
Biologics & Biosimilars, No Additional Disease & Conditions/Specialized Treatment Areas