FDA waives trial requirement for Stelera biosimilar, marking a regulatory breakthrough and potentially reducing costs.
• FDA waives clinical trial requirement for Stelera biosimilar on October 2023.
• First FDA biosimilar application without clinical testing, aligning with EMA and MHRA.
• Potentially reduces development costs and accelerates approval timelines.
The US Food and Drug Administration (FDA) has waived the clinical efficacy study (CES) requirement for a biosimilar of Johnson & Johnson’s Stelara (ustekinumab). This decision marks the first time the FDA has approved a biosimilar application without requiring clinical testing. The move aligns the FDA with the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), supporting ongoing regulatory harmonization. Read more.
Why it matters
This regulatory breakthrough could significantly impact the economics of biosimilars. By eliminating the need for costly clinical trials, the FDA’s decision may lead to reduced development costs and faster approval timelines. Consequently, this could make biosimilars more competitive with generic small-molecule drugs in terms of pricing. The decision also opens the market to mid-sized and small generic companies, which previously faced high entry barriers.
What’s next
The FDA’s acceptance of this application sets a precedent that could reshape the biosimilar landscape. Pharmaceutical Scientist founder Professor Sarfaraz Niazi, who filed the application, emphasized that analytical similarity and immunogenicity studies are sufficient to confirm biosimilarity. As a result, more companies may follow suit, potentially expanding global access to biosimilars. For further insights, visit our Regulatory & Approvals section.