The Biosimilars Price Competition and Innovation Act (BCPIA) of 2009 created a biosimilars approval pathway in the US with the goal of increasing access safe and effective biological treatment options that are more cost effective than standard biologics. Since then, significant progress has been made in the science and regulation of biosimilar development and approval, and cooperative efforts among global regions is leading to better alignment on these issues.

To date, the FDA has approved 18 biosimilars, yet only seven are currently available on the market. Though this represents roughly a doubling of the marketed products in the past year, in the US especially, uptake of biosimilars has been slower than anticipated. Barriers to a robust biosimilars market are well understood:

• Commercial challenges such as restrictive formularies, contracting, rebates, and other pricing issues
• Legal challenges including extensive patent estates, unresolved questions from BPCIA, and settlements between originator and biosimilar companies
• Educational needs for healthcare providers and patients about the effectiveness and safety of biosimilars

These challenges are complex, interrelated, and best addressed by stakeholder collaboration. At DIA's Biosimilars Conference, manufacturers, regulators, payers, prescribers, and patients will come together to apply current biosimilar developments, experience, and the newest thinking to analyze strategies and next steps for improving biosimilar access and uptake.

Check out our 2019 Program!