Festival of Biologics Basel

A consultant who specializes in helping Chinese biosimilar companies market their products in the European Union discusses the challenges and opportunities.

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.

Expecting real-world evidence to confirm safety and efficacy of biosimilars is asking too much, Uwe Gudat, a pharmacovigilance expert from Fresenius Kabi, said at the Terrapinn Festival of Biologics Basel 2020.

Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but modifications to regulatory policy could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.

Certain biosimilar studies are performed out of an abundance of caution and good marketing sense, although science has leapfrogged the need for these trials, panelists said at the Terrapinn Festival of Biologics Basel 2020.