Since Sandoz received approval for Omnitrope in 2006, the first biosimilar medicine in Europe, the science behind their development has evolved significantly. With 69 biologics expected to lose protection by 2030 in Europe, the next five years presents a huge opportunity to expand access to these potentially life-changing medicines. However, to realise this potential, we must continue modernising and aligning regulatory guidance across regions – creating a more consistent, science-led approach that brings biosimilar medicines to patients without unnecessary delay.

Encouragingly, key regulators are starting to act. The European Medicines Agency recently published a draft reflection paper proposing that comparative efficacy trials be removed in most cases – a shift toward more streamlined approvals. This follows the UK Medicines and Healthcare Products Regulatory Agency’s 2022 update, which removed the default requirement for these trials where clear scientific rationale exists.

There’s also a growing opportunity for global convergence. Aligning regulatory pathways around the latest science could streamline development and bring biosimilar medicines to patients faster. For example, following Brazil’s 2022 introduction of a fast-track process for products approved by trusted international regulators, including the EMA, the Food and Drug Administration (FDA) and Health Canada, the number of approved biosimilar medicines in the country has grown significantly. This now positions Brazil among the top global markets for biosimilar authorisations, second only to the EU.

In Europe, this often involves divisional patents, where multiple overlapping patents are filed from a single application to prolong protection and create uncertainty. In the US, dense ‘patent thickets’ around single products can make litigation lengthy and expensive, even after regulatory approval. Both approaches extend exclusivity far beyond the original patent intent and can deter biosimilar medicine development entirely.

We need more balanced IP frameworks that protect genuine innovation while enabling timely, commercially viable biosimilar medicine entry. This includes greater transparency, discouraging duplicative filings, and streamlining legal processes. With clearer, fit-for-purpose IP systems, patient access expands, healthcare systems save billions, and manufacturers maintain the incentive to invest the significant time and capital required to bring a biosimilar medicine to the market. 

From a payer perspective, that may seem like a win, but it’s a short-sighted view. If biosimilar medicines aren’t being used, their future becomes uncertain, and while that might appear to affect mainly developers, the consequences are far more wide-reaching. Without biosimilar medicines in the market, the competitive pressure to keep prices low disappears, and with it the access benefits and cost savings that patients and healthcare systems rely on. We’re already seeing what happens when this dynamic breaks down. For example, we’re now facing a growing biosimilar void, where many biologic medicines have lost, or will lose, patent protection but have no biosimilar medicine candidate in development. In the US alone, this represents a missed savings opportunity of up to $189 billion over the next decade. Those lost savings don’t just impact today’s budgets; they also reduce the financial headroom for originator companies to invest in the treatments of tomorrow. 

Tough launch conditions for biosimilar medicines can make this even harder. Mandatory discounts, external reference pricing, and automatic price cuts can make market entry for some molecules commercially unsustainable. Single-winner tenders focused only on the lowest price, and rebate structures that favour originators, further distort the market. With biosimilar medicine development taking up to nine years and $300 million per candidate, continued investment depends on fair, functional market conditions. 

Moving forward, we need smarter frameworks that look beyond price alone and consider broader system value. Procurement should reward quality, supply resilience, and long-term value. Reimbursement systems must make biosimilar medicines a viable choice for prescribers by ensuring they are not financially disadvantaged for using them. Pricing models must promote healthy and sustainable competition over time. Ultimately, our systems must recognise biosimilar medicines as more than simply a short-term cost-containment tool. They are a strategic lever for value-based healthcare, helping health systems to stay sustainable while expanding access to life-changing biologic treatments for patients, both now and in the future.

The industry has made real progress, but we’re not there yet. We need to keep investing in targeted, evidence-based education that speaks to the needs of prescribers, pharmacists, and patients. We also need to keep building strong advocacy networks with credible voices across healthcare systems that can reinforce trust and help make biosimilar medicines an even more mainstream aspect of patient care.

Because at the end of the day, no matter how strong the policy environment is, if prescribers don’t trust biosimilar medicines, patients won’t either. And without that trust, biosimilar medicines will always fall short of their full access potential.

At Sandoz, our purpose is to pioneer access for patients. That’s not just about developing high-quality biosimilar medicines, it’s also about driving the changes needed to help them succeed once they’re available.

But we can’t do it alone. Making biosimilar medicines work at scale takes strong collaboration across industry, regulators, policymakers, payers, and healthcare professionals. If we can come together with a shared commitment to improving access, we can build a system where biosimilar medicines can reach more people, more reliably, and make an even bigger impact with the patients who need them the most.