Biosimilar assessment a goal of FDA modernisation plan
Technological advances are challenges and opportunities for the US Food and Drug Administration (FDA) and to keep pace the agency has drafted a plan to modernise regulatory science in key areas.
“As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy”, said Margaret Hamburg, commissioner at the FDA.
A section of the plan is dedicated to new approaches to improve product manufacturing and quality. In the chapter the FDA says it must collaborate with industry and academia to understand how new technologies affect safety, efficacy and quality.
Development of new analytical technologies is one area of focus. In particular, the FDA wants methods to: compare biosimilars to reference products; and measure physical structure, chemical properties and safety of nanomaterials and complex dosage forms, such as transdermal patches.
Supporting development and evaluation of novel manufacturing methods is another priority area. Continuous manufacturing, the role of excipients and complex dosage forms, and the impact of novel technologies on product failure rates are fields in which the FDA wants to collaborate with industry.
Cutting risk of microbial contamination is the third and final topic in the manufacturing sector. To meet this goal the FDA wants to: develop sensitive, high-throughput methods to detect microbial contaminants; find alternatives to conventional sterilisation; and create reference materials.
QbD
A subsection of the document focuses on Quality-by-Design (QbD). FDA QbD efforts are now focused on three areas that the agency briefly outlines in its strategy document. The priority areas are:
- Continuous processing
- Use of process analytical technologies (PAT)
- Development of statistical approaches to detect changes in process or product quality
