FDA Update: Improving Access to Biosimilar Drug Products

The need to enhance the transparency of the pharmaceutical supply chain and ensure availability of generic and biosimilar drug products has become more evident during the pandemic. It is important to recognize the regulatory challenges involved in ensuring the quality and integrity of biosimilar formulations. The biosimilar market continues to grow significantly, with notable new drug approvals for 2020. An FDA spokesperson answered U.S. Pharmacist's questions regarding the latest biosimilar regulations. Even as the FDA moves to improve access to biosimilar drug products, strategies some manufacturers use to navigate around the patent and regulatory systems to prolong the market exclusivity for brand-name products are also impacting accessibility.