Designing Today's Policies for Tomorrow's EU Biosimilar Portfolios

Julie Maréchal-Jamil, MScDirector, Biosimilars Policy and ScienceMedicines for Europe

Today in the European Union, we can be proud and celebrate the fact that in 28 EU Member States, biosimilar medicines are in use, and competition in the biological medicines field has consistently brought value for patients and healthcare communities. In general, broader access (more patients treated) is an immediate consequence of biosimilar competition, and earlier access to treatment (where clinically appropriate) has been observed in a number of countries.

• Is this homogeneous? Not entirely. Disparities remain among the different biosimilar medicines, therapy areas, countries, and even regionally within countries.
• What can be said about the trend? From a bird’s eye view, it looks like the early biosimilar adopters are getting better at biosimilar introduction and use, learning from experience and continuously adjusting frameworks. It does, however, point towards an even greater gap with late adopters, which also happen to be countries with the highest economic constraints (lowest pharmaceutical budgets). Intuitively, those countries would be the ones benefiting the most from the introduction of biosimilar medicines in terms of healthcare gains.

A concern is that future access to biological therapies, including their biosimilars, has not been getting the attention it really deserves. The biological medicines portfolio set to lose exclusivity over the next decade bears little resemblance to the ones we’ve experienced thus far. Thoughtful adjustments to existing frameworks will therefore be needed to secure continuous benefits from biosimilar competition over time. Now, how do we do that?

The primary colors of a sustainable biosimilar opportunity

As with primary colors, experience has taught us that there are certain rules which, when mixed and adapted, foster different colors of a sustainable biosimilar opportunity.

• Reaching the point of trust: inclusiveness and empowerment

When comparing and contrasting stories from EU Member States, one has to acknowledge that the disparities in stakeholder awareness, understanding, and empowerment on biosimilar medicines topics are tremendous. It is therefore by design that some countries, such as Denmark, Germany, or the United Kingdom have managed to bring all the important stakeholders onboard the biosimilar train. At the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held November 2-6 in Copenhagen, Denmark,¹ it was striking to see that, despite 13 years of biosimilar medicines experience in the European Union, a large proportion of EU medicines agencies still lack the minimum information on these medicines, constituting the very first barrier to biosimilar adoption.

• Supporting the use of biosimilar medicines and multiple actors on the market

Hearing directly from some EU Member States at the recent annual European Commission multistakeholder workshop, held on October 29, 2019, it was clearly apparent that benefits can only be obtained if biosimilar medicines are used in clinical practice. Whereas in Germany, physician associations report great biosimilar uptake and evolving prescription trends, in Slovakia, the existing framework appears to disincentivise by design the use of biosimilar medicines. Stakeholders concurred in discussions that a sole focus on price erosion fails to create a conducive environment for competition in the market, as does the shift from one monopoly (originator) to another monopoly (biosimilar).

• Sense of purpose: re-investment in health at the heart of healthcare policy priorities

While benefit-sharing has been emulated across the European Union and internationally (eg, in Canada), it remains a rather underused policy intervention. Transparent reallocation of the biological medicines budget has been introduced in the United Kingdom and more recently in France, by means of a pilot project whereby the prescription of a selection of biosimilar medicines rewards the hospital departments involved in the prescription for reinvestment in patient care.

Obviously, when seeking the optimal shade of color, failing to combine these 3 primary colors will not deliver on the promise of earlier, broader, and future access to biological medicines and healthcare. To date, a limited number of EU Member States successfully combine trust, competition, and sense of purpose, translating into variable benefits in terms of access. In certain instances, continuous learning from experience has allowed policy frameworks to morph and get significantly ahead of the game.

The good news is that there is a lot of cumulated experience at national, regional, and local levels. Many color combinations have been tried out, and progress has been made in extending the reference color palette.

The ideas are there, the implementation is on the way, and the results should be as well where time is allowed for measures to bear fruit and where monitoring informs policy-making via feedback mechanisms.

Beyond primary colors: the political outlook, sustainability of healthcare systems, and equitable access to all medicines

The EU institutions are currently getting organised for the next 5 years, and this is an opportunity to shape future-proof biosimilar and access frameworks.

• The European Medicines Agency is developing its Regulatory Science Strategy 2025: regulators play an important role in access to medicines. Regulators’ scientific rigour and experience is the foundation of stakeholder education. The fitness-for-purpose of regulatory requirements and processes condition, in part, the development costs and marketing authorization process as to how early, how broad, and how sustainable access can be.
• Toward the end of 2019, a brand-new incoming European Commission will take the lead. As it prepares to kick off a renewed political mandate for a 5-year term, its president, Ursula von der Leyen, has set the tone when it comes to promoting public health. The commissioner-designate for health has been tasked to support “European Member States in constantly improving the quality and sustainability of their healthcare systems.” The mission letter also insists on the importance of balancing the “supply of cost-efficient medicines” and “the European pharmaceutical industry to ensure it remains an innovator and world leader.”

So we have a plan: earlier, broader, and future access will drive the evolution on the EU biosimilar policy framework to ensure that national healthcare systems deliver on their commitment to more equity in access to health and healthier communities.

We are planning to take the pulse on these various aspects at the occasion of our upcoming Biosimilar Medicines Conference on March 26-27, 2020, in Amsterdam; check our programme online on November 15, 2019.

Reference

1. Barbier L, Mbuaki A, Simoens S, Vulto AG, Huys I. The role of regulatory guidance and information dissemination for biosimilar medicines—the perspective of healthcare professionals and industry. Presented at: ISPOR Europe 2019; November 2-6, 2019; Copenhagen, Denmark.