Sens. introduce follow-on biologics bill
Under the approval process in the bill, a biosimilar applicant would be required to demonstrate there are no clinically meaningful differences in safety, purity and potency between its product and the branded product by using analytical data, animal testing and one or more clinical studies, unless deemed unnecessary by the FDA.
The FDA could approve a biosimilar product as interchangeable, meaning it could be substituted without the intervention of the healthcare provider who prescribed it. Showing interchangeability would require evidence that the biosimilar product will produce the same clinical result as the brand product in any given patient and that it presents no additional risk in terms of safety or diminished efficacy.
The act would provide incentives for development of new biological products and interchangeable biosimilar products—12 years of data exclusivity for the company during which a biosimilar product could not be approved, and one year of exclusivity for the first interchangeable biological product.