Support for introduction of a global regulatory process for biosimilars

The majority of surveyed US and European physicians and payers are in favor of the introduction of a global regulatory pathway for biosimilars, while the European Medicines Agency's recent decision to accept reference products sourced from outside Europe demonstrates a growing interest in simplifying approval of biosimilars, says health care advisory firm Decision Resources’ BioTrends Research unit.

According to its Biosimilars Advisory Service: Global Pipelines, Regulatory Pathways, and Key Stakeholder Perspectives of Biosimilars, for a global pathway to become a reality, the biosimilar market must overcome further hurdles involving the source of reference product, differences in scope and trial requirements across regulatory agencies.

"A global biosimilar pathway would eradicate the need to repeat clinical trials in multiple countries, which in turn would reduce development costs and enable companies to lower prices, as well as improve speed to market," said Kate Keeping, director of the Biosimilars Advisory Service at Decision Resources.