Biosimilars | Access & Reimbursement | US/EU | 2025
Biosimilar regulations and guidance have been defined, at least in draft form, in most the world’s leading pharmaceutical markets. In many cases, biosimilar guidance is based on that of the EMA, which first implemented a development framework for biosimilars, but the degree of similarity and granularity varies by country. Payers play a significant role in defining the commercial success of biosimilars—as well as their reference brands—as they decide which products are granted formulary access and preferential reimbursement. As such, it is necessary for biosimilars developers and manufacturers of branded biologics to understand payers’ perceptions and attitudes toward biosimilars, which factors influence payer decisions regarding biosimilars, and how these factors vary across different markets.
Questions answered
• What does the country’s biosimilar regulatory pathway dictate, and how does it differ from other markets?
• Is automatic, pharmacy-level substitution permitted?
• How are biosimilars priced and reimbursed?
• Will payers’ attitudes toward indication extrapolation restrict the use of biosimilars?
• Will payers permit patients to continue current treatment with the reference brand or encourage switching to biosimilars?
• What level of biosimilar discount do payers need to preferentially reimburse a biosimilar, and what formulary methods do payers expect to use to stimulate uptake of biosimilars at various price discounts?
• Do payers expect availability of biosimilars to increase the total volume of the drug used?
• What are the key strategies employed to drive biosimilar uptake?
Primary and secondary research: Primary market research includes survey of 60 U.S. payers and interviews with 10 EU5 KOLs; extensive secondary research conducted by subject matter experts
Key drugs covered: Admelog / Insulin Lispro Sanofi, Aranesp, Avastin, Basaglar / Abasaglar, Dupixent, Enbrel, Fasenra, Herceptin, Herzuma, Hulio, Humalog, Humira, Inflectra, Kanjinti, Kesimpta, Neulasta, Neupogen, Nivestim / Nivestym, Nucala, Nyvepria, Ocrevus, Prolia, Remicade, Remsima, Rituxan / MabThera, Semglee, Stelara, Trazimera, Truxima, Tysabri, Udenyca, Zarzio / Zarxio, Ziextenzo
Content highlights: Reimbursement and contracting, access and prescribing, opportunities and challenges for emerging therapies
Product description
Clarivate’s Biosimilars | Access & Reimbursement provides a detailed view of the regulatory pathways and payer policies for biosimilars in key markets so that clients can optimize their market access strategy and determine how to best position their brand to specific stakeholders.
Biosimilars | Access & Reimbursement | Global Landscape provides an overview of the regulations, guidance, pricing, and reimbursement environment for biosimilars in the United States, Europe, Japan, and rest of world.
Biosimilars | Access & Reimbursement | Payer Insights provides deep insights into the current and future market access environment for biosimilars in the United States and Europe and explores strategies used in formulary management and expectations on pricing.
