HHS must publish biosimilar exclusivity deadlines online

What does this do?

This bill requires the Department of Health and Human Services to publicly post deadlines showing when biological drugs lose their legal protection from cheaper competitor versions called biosimilars. For newly approved drugs, that information must be posted within 30 days of when the expiration date can first be known. For drugs already on the market when the law takes effect, the agency has either 30 days from when the date becomes known or up to 2 years to post it.

Who does it affect?

This bill affects companies that make biosimilars and companies that make the original biological drugs. Patients and insurers are also affected once those protection periods expire and lower-cost competition becomes possible.

Why does it matter?

Right now, exclusivity expiration dates are not always listed publicly in a timely way, which can make it harder for biosimilar makers to know when they are legally allowed to enter the market. This bill sets clear posting deadlines to make that information available sooner.

Where does it stand?