Reference Product

Producto de Referencia

In 9 languages

LanguageTerm
EnglishReference Product
Spanish (Español) Producto de Referencia
Chinese (中文) 参考产品(原研生物制品)
Korean (한국어) 참조 제품 (원조 생물의약품)
Vietnamese (Tiếng Việt) Sản phẩm Tham chiếu
Filipino (Tagalog) Reference Product (Orihinal na Biologic)
Portuguese (Português) Produto de Referência
Thai (ภาษาไทย) ผลิตภัณฑ์ชีววัตถุอ้างอิง
Japanese (日本語) 参照製品(先行バイオ医薬品)

What it means

A reference product is the original FDA-approved biologic drug against which a biosimilar is evaluated for approval. Biologics are complex medicines derived from living cells—such as insulin analogs, monoclonal antibodies, and certain vaccines. When a manufacturer seeks to produce a biosimilar, the FDA requires clinical evidence demonstrating it is highly similar to the reference product with no clinically meaningful differences. Knowing which reference product a biosimilar was approved against confirms both are FDA-sanctioned options. Biosimilars typically cost less than the reference product, which can reduce your prescription costs.

How to say it

Sentences a patient might use with a doctor, nurse, pharmacist, or insurer:

REF-er-ens PROD-ukt

producto de referencia

Also called 'originator biologic' or 'brand-name biologic'

También llamado 'biológico originador' o 'biológico de marca'

Pharmacist might say: 'This biosimilar references [product name]'

'Este biosimilar tiene como referencia al [nombre del producto]'

Where you'll see it

FDA biosimilar approval lettersDrug formulary listsPharmacy benefit manager documentsPrescriber information sheets

Related terms

Sources

US Glossary Español A–Z US Codes United States

Last reviewed: September 2026