Regulatory Developments Impacting Biologics

In this episode of Ask the Expert, Siegfried Schmitt, vice president, Technical, at Parexel, and Susan Schniepp, distinguished fellow at Nelson Labs, discuss regulatory and compendial announcements affecting biologics manufacturers.

The conversation was prompted by a question a PharmTech reader seeking to understand the significance of new publications from the FDA, the US Pharmacopeia (USP), and European regulators. Schniepp notes that these regulatory announcements are arriving in close succession, which is notable and appears to reflect a coordinated effort to support the rapidly evolving biologics field.

On the USP side, new methods for biologics have been released without accompanying specifications.1 Schniepp views this as a deliberate move to assist manufacturers by providing validated methods while leaving specification-setting to individual companies based on their specific product. This indicates USP is helping streamline chemistry, manufacturing, and controls (CMC) sections in regulatory filings without imposing a one-size-fits-all standard.

In Europe, the Critical Medicines Act, which was agreed upon in 2025, focuses on reducing drug shortages and eliminating supply chain bottlenecks.2,3 Schniepp highlights the concern that some critical raw materials or components used in biologics may be available from only a single supplier. If that supplier experiences a disruption, it can affect the entire industry. The act aims to address these single-source vulnerabilities and strengthen supply chain resilience.

The FDA, meanwhile, has issued a draft guidance on leveraging prior knowledge in the development of human gene therapy products incorporating genome editing.4 Rather than requiring each company to build a completely independent platform from scratch, the guidance would allow manufacturers to reference previously published studies and data to support their CMC filings, which could be a significant potential time-saver for an area where knowledge is often concentrated among a small number of firms. Both speakers emphasize that this guidance is still in draft form, with a public comment deadline of September 1, 2026, and encourage manufacturers to submit their perspectives.

How Are Regulators Supporting Biologics Development?

Schmitt broadens the conversation to the underlying intent behind these developments. Biologics, he notes, are frequently life-saving treatments that regulators are motivated to help bring to market. The challenge is not just regulatory approval, but ensuring these therapies can actually reach patients. That involves rethinking supply chains and manufacturing models. For cell and gene therapies, in particular, traditional centralized manufacturing and long-distance shipping are often not viable options. Both experts point to distributed, decentralized manufacturing (i.e., producing therapies physically closer to patients) as a likely direction for the industry.

Schniepp states that, in some cases, the final steps of manufacturing may need to occur in a clinical or hospital setting, such as combining a lyophilized product with water for injection. This requires close coordination between manufacturers and healthcare providers and must be factored into regulatory planning.

Rather than viewing regulators as lagging behind innovation or creating unnecessary burdens, the FDA, EMA, and USP are trying to keep pace with a fast-moving field and actively supporting industry progress, according to Schmitt and Schniepp, which is a positive development for patients, companies, and the broader ecosystem alike.

Biologics manufacturers should pay close attention to these announcements and engage with the process by submitting comments to both the FDA on its draft guidance and to USP on its proposed methodologies. Regulatory input from industry practitioners helps shape practical, workable standards.

Click on the video above to watch the experts answer the question:

“My company manufactures biologics, and we saw some recent actions by FDA, USP, and the EU, how do these regulatory actions impact us as a biologics manufacturer?”

References

1. USP publishes product-specific emerging biologics standards for public comment. USP. Press release. June 1, 2026. https://www.usp.org/news/usp-publishes-product-specific-emerging-biologics-standards-for-public-comment
2. EMA. EMA welcomes political agreement on the Critical Medicines Act. News release. ec.europa.eu. 12 May 2026. https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1017
3. EC. Proposal for a Critical Medicine Act. ec.europa.eu. 11 March 2025. https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en
4. FDA issues draft guidance to help accelerate cell and gene therapies for patients. FDA. Press release. June 2, 2026. https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-help-accelerate-cell-and-gene-therapies-patients

About the experts

Susan J. Schniepp is distinguished fellow at Nelson Labs and a member of PharmTech's Editorial Advisory Board.

Siegfried Schmitt is vice president, Technical at Parexel and a member of PharmTech's Editorial Advisory Board.