How to solve the paradox of modern healthcare

There’s an alarming paradox in modern healthcare: the better it gets, the more difficult it can be to offer it to everyone.

Over the past few decades, a series of medical breakthroughs – particularly in the field of biologic medicines -- has led to more advanced therapies that have transformed millions of lives. At the same time, though, our healthcare systems face steadily increasing costs, driven by a growing and ageing population.

The extra social and economic burden of the coronavirus pandemic has further compounded the challenge of ensuring equitable and sustainable access to healthcare. Addressing this in a balanced way requires a broad range of solutions, but one of the most powerful options has been available for well over a decade: more affordable, high-quality versions of existing biologics, known as biosimilars.

Fifteen years ago, Sandoz launched the world’s first biosimilar. Since then, this new class of medicines has had a very positive impact on patient access and the sustainability of healthcare systems -- but we still have quite a way to go to unlock their full potential.

In the US, for instance, biologic medicines represent just 2% of pharmaceutical prescriptions by volume but 37% of the total cost; however, biosimilar competition is still at a relatively early stage.

In Europe, biosimilars have captured 10% of the total biologics market by value, and much more by volume; the difference between the two figures reflects savings due to biosimilar competition. However, not all patients have the same access to biosimilars: uptake still varies greatly, not only across countries and therapy areas but also within countries.

So what’s next?

My hope is that, 15 years from now, we will be able to look back on an inflection point, when high-quality, more affordable and life-changing biologics became widely accessible to patients worldwide. Some stretches of the path towards that goal may look different by market and by region, but many of the prerequisites for success will be surprisingly similar.

Let’s start with the differences. In Europe, with its growing tendency towards price-driven tenders for off-patent medicines, a major challenge will be to promote continued biosimilar uptake without encouraging an economic “race to the bottom” that ends up driving much-needed competition out of the market (i.e. leaving us without competition after a reference biologic loses its market exclusivity).

In the US, where the biosimilar market is just beginning to take off, the commercial challenges are more complex (as is the healthcare system). Priorities will include policy changes to ensure reimbursement models do not favor the most expensive option, to remove unnecessary hurdles to biosimilars being included in formularies, and to minimize out-of-pocket costs.

However, ensuring the success of biosimilars is not just a question of optimizing commercial models. One reason why biosimilar uptake is not yet where it should be is that, 15 years after the first product launch in Europe, the simple scientific principles that underlie them are still not fully understood by all.

As an industry, we need to do a better job of explaining two simple concepts: that all biologics are naturally subject to variability (because they are all made from living organisms) and that we need to continue to evolve regulatory requirements, with an appropriate balance of science and ethics.

Follow the science

Let’s start with the first point: Regulatory agencies including the EMA and the US FDA have decades of experience dealing with this natural inherent variability. For instance, routine manufacturing changes typically require no new clinical studies, as long as the critical quality attributes stay the same: the underlying principle is known as “comparability.”

Which brings us to the second point. In the early days of biosimilars, regulators requested comprehensive Phase III clinical trials to “confirm” safety and efficacy for all biosimilars, as biosimilars were a “new” class of medicines. Fifteen years on, there is a growing scientific discussion about whether advances in technology and scientific understanding would now allow us to further tailor the biosimilar development process, by reducing both timelines and cost. A move in this direction would not only increase patient access to currently planned biosimilars, it could also significantly improve the market prospects for biosimilars of smaller reference biologics.

The history of science is full of simple ideas that seem obvious in retrospect, but took surprisingly long to be accepted (just think of Galileo and Copernicus). I believe it’s no exaggeration that some of the current debates around biosimilars will be viewed with equal astonishment a few decades from now.

In both scientific and economic terms, biosimilars offer a simple and meaningful way to help solve the paradox of modern healthcare. However, we should not take their positive impact for granted; we need to continue to tailor regulations and policies to support biosimilar uptake if we are to realize their full potential for patients, HCPs and healthcare systems. Here’s to the next 15 years...