Since their first U.S. approval in 2015, biosimilars have had the potential to serve as analogs to generic drugs in the biopharmaceutical space. In the initial years, biosimilars faced barriers such as regulatory approval process and patent litigations, interchangeability status, provider reimbursement, and prescription drug rebates. The obstacles appeared to stall their momentum. Yet more recently, notable progress has been made toward reducing these barriers and creating opportunities for biosimilar uptake. In this paper, we discuss:
- Biosimilar landscape
- Evolution of the barriers
- Formulary coverage and uptake
- How the Inflation Reduction Act may impact the market