The FDA has approved 23 biosimilars since 2015, and many companies are considering “interchangeable” status for them, meaning they will be able to be substituted for their more expensive branded counterparts without the prescriber’s permission. In May, as part of its Biosimilar Action Plan issued in late 2018, the FDA provided guidance to manufacturers clarifying the steps they need to take to ensure their biosimilars will be approved as interchangeable. That followed close behind the new budget act, which included a mandate that biosimilars be included in the Medicare Part D coverage gap discount—a change that’s expected to further drive the demand for biosimilars. These moves come amid an ongoing debate about the rising cost of drugs and how policymakers might intervene to bring down prices.
- What manufacturers of interchangeable biosimilars need to do during the development process to maximize chances of approval and what they need to know about how it will affect pricing.
- How biosimilars being treated as branded drugs in the Part D coverage gap affects the marketing challenge for developers of biosimilars, and how they can adopt new strategies for negotiating with private payers for preferential coverage.
- Current proposals for additional legislation on drug pricing and how that could affect biosimilar development going forward.