Here you’ll find concise answers to common questions about biosimilars, grouped by general subject matter. Click or tap the “+” to expand for answers.

Biosimilars and generics — and the differences in production and labeling

Is “biosimilar” just another word for “generic”?

What is a reference product?

How distinct are biosimilar labels from their reference products?

Are biosimilars identical copies of their reference product?

How do biosimilars differ from generics?

How does the biosimilar label differ from its reference product’s?

What is the clinical data used in the biosimilar label?

Extrapolation, interchangeability, and substitution

What is “interchangeability” and what does it mean to prescribers?

Must a pharmacist notify the prescriber that he or she intends to substitute for a prescribed product?

Is “Indication Extrapolation” automatic for biosimilars?

Questions and challenges in biosimilar naming, financial assistance, and reimbursement

What are some considerations in terms of the naming of biosimilars?

How might the pricing or contracting for reference products be impacted by biosimilar products entering the market?

How will Medicare reimburse for physician-administered biosimilars?

Will biosimilars be assigned to the same HCPCS code (commonly referred to as J-code) as their corresponding reference product?

FDA guidance and requirements regarding biosimilars

Is substitution regulated by the FDA?

What does the FDA recommend be in the biosimilar’s label?

What does the FDA require of a biosimilar relative to its reference product?

Is the approval process for biosimilars as rigorous as reference product biologics?