FAQ: Understanding Biosimilars, Biobetters, and Interchangeability

1. What are biosimilars?

Biosimilars are large-molecule therapeutics designed to be highly similar to an original brand-name biologic already approved by regulators. Biosimilars are evaluated through rigorous analytical assessments to ensure they match the reference biologic in structure and function.

2. What does "interchangeable" mean for a biosimilar?

An interchangeable designation allows a pharmacist to substitute the biosimilar for the original brand-name biologic without a new prescription from a doctor. This status is granted after assessments prove the biosimilar provides the same clinical result as the reference biologic.

3. Which biosimilars gained interchangeable status in 2024 and 2025?

In May 2024, FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) for treating rare blood and immune disorders. In April 2025, YUFLYMA (adalimumab-aaty) received an interchangeable designation as a high-concentration, citrate-free version of the blockbuster biologic Humira (adalimumab).

4. How do "biobetters" differ from biosimilars?

Unlike biosimilars, which aim for near-identity, biobetters are modified versions of existing biologics designed to offer improved performance or better patient outcomes. Developing these requires balancing higher costs and resources against the potential for superior medical benefits.

5. Why is the number of biosimilars expected to grow over the next decade?

The biopharmaceutical industry expects a significant surge because more than 100 next-generation biologics will lose their patent exclusivity within the next 15 years. This "patent cliff" creates a healthy pipeline that is expected to benefit society by providing more affordable treatment options.

6. How is access to these therapeutics expanding outside the United States?

Global partnerships are localizing production, such as the 2025 agreement to expand biosimilar access in the Middle East and North Africa (MENA) for gastrointestinal and neuro treatments. Additionally, the European Commission recently approved biosimilars for conditions like psoriasis and multiple sclerosis.

7. What medical conditions can be treated with these new therapies?

Recent biosimilar approvals have expanded options for multiple sclerosis, moderate to severe asthma, and chronic rhinosinusitis. They are also becoming available for rare diseases like paroxysmal nocturnal hemoglobinuria and common conditions like persistent food allergies.

8. How do regulators ensure these products are safe for patients?

Regulators like the European Medicines Agency and FDA utilize tailored analytical strategies and process validation to ensure safety and quality. Manufacturers must demonstrate analytical excellence and process consistency before these drugs reach the market.