July 2, 2025

Prof. Alan Lyles: How Similar Do Drugs Need to Be to Achieve Widespread Marketplace Acceptance?

Prof. Alan Lyles of UBalt's School of Health and Human Services
Prof. Alan Lyles

Dr. Alan Lyles, the Henry A. Rosenberg Professor of Government, Business, and Nonprofit Partnerships in The University of Baltimore's School of Health and Human Services, senior research associate in the Schaefer Center for Public Policy, and an internationally recognized expert on access to pharmaceuticals, is principal author of a paper in the Generics and Biosimilars Initiative (GaBI) Journal that presents the findings of a symposium on global trends in the use of "biosimilars"—pharmaceuticals designed to have active properties similar to those of a drug that has previously been licensed.

 

The paper describes the deliberations of an online symposium hosted in December 2023 by the University of Helsinki, Helsinki University Hospital, and University Pharmacy (Yliopiston Apteekki) Helsinki to provide "an overview of global trends in biosimilar use and a systematic examination of the implications of automatic substitution for diverse stakeholders." Dr. Lyles gave a keynote presentation during the symposium.

 

According to the GaBI article, healthcare systems around the world have made moves in recent years to promote the use of cost-effective biological and biosimilar medicines.

 

"With biologicals and biosimilars playing a significant role in treatment plans, policymakers and healthcare professionals have explored strategies such as physician guidance and pharmacist-led substitution to enhance their accessibility and affordability."

 

These efforts, according to Dr. Lyles and his co-authors, have met with limited success.

 

"So far, there has been too much focus on the attributes and regulatory pathways for biosimilar products and not enough on understanding the system in which they are used," the paper asserts. "Price, biosimilar marketing authorization, and technical considerations are not the full explanation for a nation or a region's adoption and diffusion of biosimilar use. After those concerns and the issue of 'how similar is similar enough' are met, transnational comparisons suggest that trust can strongly influence biosimilar use. Patient and physician acceptability are a fifth hurdle for biosimilar adoption, beyond evidence of safety, efficacy, quality, and cost effectiveness."

 

Read the article in the Generics and Biosimilars Initiative (GaBI) Journal.

 

Learn more about Prof. Alan Lyles and UBalt's School of Health and Human Services.

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