A recent publication in the European Journal of Clinical Pharmacology shows that the use of biologic drugs often changes significantly after they are approved for the market. Researchers analyzed 53 indications for biologic drugs that received a positive opinion from the EMA between 2006 and 2010 and tracked how recommendations for use evolved through 2025—both in clinical guidelines and in the official summary of product characteristics (SmPC).

The study shows that for nearly half of the indications examined, the official product information (SmPC) was amended over the years. In addition, differences were found between current clinical guidelines and the registered product information for three-quarters of the indications. Notably, these guidelines generally recommend a more cautious use of biologics than the original registration.

The researchers also note that studies leading to an expansion of use are often funded by pharmaceutical companies, whereas publicly funded research more frequently results in recommendations for more effective and more limited use. The study thus underscores the importance of independent post-marketing research to determine the most rational and sustainable use of medicines.

The findings are closely aligned with FAST’s mission: to promote the timely development of knowledge regarding the optimal, affordable, and sustainable use of innovative therapies. The authors advocate for initiating research into the most effective use of medicines sooner after—or even concurrently with—market authorization, so that both patients and society can benefit from optimal care sooner. Ideally, SmPCs should also be updated in a timely manner to better align with treatment guidelines.

View the publication here: Penninx et al. (2026), From authorisation to clinical practice: evolution of the use of biological medicines according to the SmPC and guidelines (2006 to 2025), European Journal of Clinical Pharmacology.