Role at ICON:
I coordinate and spearhead ICON’s services in the biosimilars arena, a responsibility that includes leading the company’s Biosimilars Advisory group. This group brings together expertise
in such wide-ranging areas as market assessment, quality, pre-clinical, clinical pharmacology, clinical development, and regulatory strategy. We’re drawing on the collective knowledge
of this team to assist companies in moving their biosimilar
products through development and into the market.
Professional Background:
My academic qualifications are in the biological sciences, medical statistics, and law. Early in my career, I worked both in clinical research and in regulatory affairs for large French and U.S. pharmaceutical companies. More recently, I’ve been an
independent consultant, advising clients on a wide range
of drug development issues.
Career highlights:
Two highpoints stand out in my mind: working to gain regulatory approval for Plavix® (clopidogrel), an oral antiplatelet agent, and for Valtropin® (somatropin), one of the first biosimilar medicines to be approved in the European Union.
My involvement with Plavix is memorable because it was the first global blockbuster drug with which I was associated. And now, it’s one of the most prescribed medications in the world.
Working on Valtropin turned out to be groundbreaking in quite another way. We were developing the product before any formal regulatory pathway or guidance for biosimilars existed in Europe—
or, indeed, anywhere. So, our application for Valtropin’s marketing approval paved the way and helped to create the regulatory framework for biosimilars that now exists in Europe.
What are the most challenging factors in conducting studies with biosimilars?
The overarching difficulty is in demonstrating the similarity of
the biosimilar product to the innovator molecule. In exploring
the question of similarity, developers and regulators have to:
- Establish the criteria for similarity
- Determine the most suitable patient population
- Understand the scope of the research. If comparable efficacy
is demonstrated between the biosimilar and the innovator drug
in one autoimmune condition (for example, rheumatoid arthritis), can the comparison be extrapolated to another disease (such
as Crohn’s disease) without conducting additional studies?
What are the benefits of biosimilars?
While biosimilars are often erroneously referred to as “generic biologics,” they do, in fact, behave in the market somewhat like generics in that they strengthen competition, lower prices, and expand patient access to breakthrough medications. In the case
of biosimilars, these breakthroughs are often therapies for serious, life-altering diseases such as cancer, diabetes, Parkinson’s, and Alzheimer’s for which treatments are generally expensive.
Developing biosimilars presents drug manufacturers with
a variety of challenges—what do they need to put in place
to succeed?
Companies working in this field must have secure access to large-scale production facilities. They must also rely on individuals who have particular experience in developing biological products—from regulatory and quality to bio-analytical and clinical research.
