THE KEY CHANGES SHAPING THE NEXT DECADE IN BIOPHARMA
Biosimilars have transformed the landscape of biologic treatments, offering equally safe and effective alternatives to innovative drugs at a lower cost. Yet, despite their potential to enhance patient access and reduce healthcare expenditures, their widespread adoption hinges on more than just scientific validation—it is profoundly influenced by regulatory policies and market dynamics that dictate their viability.
Nowhere is this clearer than in Europe, which has led the way in biosimilar adoption. Since 2006, over 5.8 billion patients have been treated with EU-approved biosimilars, generating €50 billion in healthcare savings between 2006 and 2023. Globally, however, shifts in approval trends signal new competitive forces at play. Singapore now leads the world with 146 approved biosimilars, followed by India (128), the European Union (110), and the United States (60), according to IGBA’s November 2024 report. These figures highlight how regional regulatory frameworks significantly shape market access and industry growth.
Among the factors driving these trends, regulatory decisions stand as one of the most decisive forces shaping the future of biosimilars. From interchangeability guidelines to evolving approval pathways and the ongoing debate over procurement policies, understanding these shifts is key to predicting where the industry is headed.
Interchangeability: a turning point for biosimilar integration
In recent years, regulatory agencies have made significant strides to accelerate biosimilar adoption. A key milestone was the EMA’s interchangeability guidance, which established that biosimilars in Europe can be considered interchangeable with their reference products.
Previously, patients who began treatment with an originator biologic were often required to continue with the same product. Biosimilars can now be seamlessly substituted, removing unnecessary barriers to switching and expanding patient access to cost-effective biologic treatments.
The recent push to accelerate biosimilar approval and reduce trial costs
Additionally, both the EMA and FDA have taken a major step toward waiving phase 3 clinical trial requirements for biosimilars, shifting toward approval pathways based on robust laboratory PK and PD comparability studies. While this discussion remains open in the U.S., the UK has moved ahead, eliminating phase 3 efficacy trials for all biosimilars.
This shift is a game-changer for development timelines and costs, currently ranging between $100 million and $300 million over seven to eight years. Removing interchangeability studies alone could bring costs down to $75 million to $250 million and shorten development to six and a half to seven and a half years. Eliminating both interchangeability and phase 3 trials could cut costs to just $50 million to $75 million and accelerate timelines to five to six years.
These changes not only ease the financial burden on healthcare systems but also improve patient access by bringing biosimilars to market faster and at lower costs.
Beyond price: the need for a balanced approach to tendering
Yet, beyond regulatory advancements, market policies have posed another challenge. In some European countries, procurement policies have been driven exclusively by price, favoring manufacturers from lower-cost regions and discouraging many companies with innovative pipelines from investing in biosimilars. This has led to what is now known as the “biosimilar void“: a critical gap where, according to the Assessing the Biosimilar Void study conducted with Medicines for Europe, nearly 55% of products set to lose patent protection in the next 7-9 years may lack biosimilar competition.
The good news is that the market is evolving. During the 2023 Medicines for Europe conference, discussions pointed toward a shift away from a price-only approach toward a more balanced procurement strategy that considers factors like local manufacturing, quality standards, and sustainability compliance. At mAbxience, we actively collaborate with Medicines for Europe to drive this shift, ensuring that biosimilar adoption is not solely dictated by cost but also by long-term healthcare sustainability and patient access.
The future of biosimilars lies in the biosimilar developers’ agility to adapt to this ever-changing landscape. At mAbxience, we remain at the forefront of these shifts, ensuring that biosimilar adoption is driven by more than just cost, but by long-term healthcare sustainability and global patient access.
As a B2B company with close partnerships we pay close attention to understanding local markets, allowing us to overcome these challenges and drive biosimilar adoption worldwide. Discover more about our pipeline and how our CDMO solutions can help you optimize your outsourcing strategy smartly.
