An Integrated Approach to Biosimilar Development and Commercialization

The European Medicines Agency (EMA) has recently updated its overarching guidance on principles for biosimilar development. A key recent change is to allow biosimilar developers to use a comparator authorized outside the European Economic Area (EEA) as part of the clinical investigation of a biosimilar, which potentially eliminates the need to repeat clinical trials for multiple markets.

This is an exciting development for the EU healthcare industry, as the guidelines will help streamline the process by which biosimilars can be brought to market, and suggests that regulators are open to these treatment options.

To date, the EMA has approved more than 20 biosimilars, including the first two monoclonal-antibody biosimilars. As a result, the EU region has gained significant experience in the use and adoption of biosimilars. However, the rate and extent of adoption has varied widely across markets, product classes, and patient populations — adding risk and uncertainty to the potential for market uptake and access. Reasons for slow uptake include price variations, local market dynamics, competitors, stakeholder knowledge and experience with products, marketing efforts by companies and timing.

An effective market strategy

Stakeholders across the healthcare environment, from regulators to physicians, are becoming more aware of biosimilars as well as further understanding their value proposition in improving overall patient access and population healthcare outcomes.

An Integrated Approach to Biosimilar Development and Commercialization

However, in order to ensure biosimilar uptake, biopharma companies must consider targeted commercialization and market access plans that addresses the unique requirements of these treatments.

A successful biosimilar market strategy depends on acceptance by a number of key stakeholders — including governments, physicians, patients, payers and other decision-making bodies. Beyond just a lower price, these stakeholders require sufficient and long-term evidence of efficacy and safety; additionally, many stakeholders seek the kind of educational and support services that branded companies have long provided. For example, the first biosimilar growth hormones were marketed with little stakeholder educational efforts and injection devices which were not the most user-friendly – as a result, physicians and patients were hesitant to use these drugs easily and companies learned the importance of value-added services,  other than price.”

Early lessons

Biopharma companies can learn from the successes – and failures – of early biosimilar companies and drugs in order to shape their own biosimilars market roadmaps and to prepare for potential roadblocks. Early insights from the 2013 EMA approval of Remsima/Inflectra (biosimilar infliximab), for example, showed that biosimilar prescriptions for Irritable Bowel Diseases (IBD) indications, which were achieved through data extrapolation, grew more slowly than in the studied indications of Rheumatoid Arthritis and Ankylosing Spondilitis – despite the fact that payers are anxious to see increases in prescriptions of biosimilars for all approved uses. Early results suggest that studies in relevant indications may be necessary for physician adoption, and that interchangeability and/or mandatory substitution may be also be necessary to encourage adoption.

We’ve also seen success stories emerge from cross-industry collaborations, including medical associations or payers sponsoring their own studies of biosimilars to overcome obstacles and spur uptake. In one of the most noteworthy cases, The Norwegian Medicines Agency (NoMA) is proactively encouraging a substitution culture by promoting clinical studies to demonstrate Remicade and Remsima/ Inflectra’s interchangeability. This reinforces the notion that interest in biosimilars is growing, and it demonstrates how innovative collaborations can help overcome some of the biggest obstacles to success. Biopharma companies could use these early successes to foster their own collaborations, so they can increase stakeholder understanding of the biosimilar value proposition and drive more rapid uptake of these treatment options around the world.

Topics in this blog post: Biosimilars, Biologics, EMA, EU, Payers