What is a Follow-On Biologic?
A Follow-On Biologic, commonly known as a biosimilar, refers to a biological product that is very similar to an already approved biological medicine (the reference product). These products are highly similar in terms of safety, purity, and potency but may have minor differences in clinically inactive components. Follow-On Biologics are designed to treat the same conditions as their reference products.
Key features include:
- Similarity: Structurally and functionally similar to an existing FDA-approved biologic
- Safety and Efficacy: Demonstrated to have no clinically meaningful differences from the reference product
- Therapeutic Uses: Used in the treatment of chronic diseases such as cancer, rheumatoid arthritis, and diabetes
Why are Follow-On Biologics important to healthcare?
Follow-On Biologics play a critical role in the healthcare landscape by offering more treatment options and contributing to competitive pricing for biological therapies. As patents for original biologics expire, biosimilars provide an opportunity for cost-effective alternatives, which can enhance patient access to vital treatments.
Key advantages:
- Cost Savings: Follow-On Biologics generally cost less than the original reference products, reducing healthcare expenditure and improving access for patients
- Innovation Encouragement: Increased competition in the biologics market encourages continuous research and development in the pharmaceutical industry
- Healthcare Sustainability: By offering more affordable options, Follow-On Biologics help stabilize healthcare budgets while maintaining quality patient care