The U.S. Food and Drug Administration has circulated three draft guidance documents concerning its role in facilitating the development of biosimilar products. Experts are suggesting that the newly released provisions could affect everything from invention disclosure to trade secrets management within the dynamic pharmaceutical industry.
The FDA defines a biosimilar product as one that is "highly similar" to an already-approved biological product, yet retains minor differences in the structure of its clinically inactive components. This classification is distinct from generic versions of over-the-counter drugs which essentially differ in name only and are regarded as therapeutically interchangeable.
With the government agency in support of the inherent cost-efficiency of qualified biosimilar products, the pharmaceutical industry is on alert.
"Manufacturing processes are patent eligible, but require disclosure of all information about how the invention is enabled," explained Mass High Tech columnist Lori Valigra in her latest column. "But that opens the door for competitors to look at the details and design around them."
As a result, Valigra envisions pharmaceutical companies revisiting their trade secrets management protocols to potentially hide their innovations from biosimilar competitors.
As the FDA awaits public comment on its draft guidance, the scientific factors considered by the patent review committee could attract the most attention, according to Patent Docs. The structure of independent safety reviews and the operational definition of clinical significance, for example, remain open to interpretation.