Innovation in the life sciences rarely unfolds in dramatic bursts. More often, it advances through a steady accumulation of regulatory decisions, scientific evidence and coordinated policymaking. The European Medicines Agency’s (EMA) annual data on human medicines provides a uniquely comprehensive view into that evolution and the 2025 figures reveal a sector that is innovating ambitiously while navigating increasing regulatory sophistication.
In 2025, the EMA recommended 104 medicines for marketing authorisation, including 38 medicines containing new active substances that had never before been authorized in the European Union. These numbers underscore a resilient pace of innovation, particularly given the growing scientific and regulatory complexity of new therapies. [ema.europa.eu]
Breakthroughs in Therapeutic Innovation
Several approvals from 2025 stand out not only for their scientific novelty but for their potential public‑health impact. Among these were:
- the first medicine to treat non‑cystic fibrosis bronchiectasis,
- a first‑in‑class treatment to delay the onset of stage 3 type 1 diabetes, and
- the first oral medicine for postpartum depression.
These milestones illustrate how pharmaceutical R&D is expanding into conditions historically underserved by innovation. They also highlight the strategic importance of early regulatory engagement, well‑structured development plans and clear demonstration of clinical relevance, factors increasingly essential to securing approval for first‑in‑class therapies.
In addition, the EMA recommended 16 new medicines for rare diseases in 2025, including the first treatment for Wiskott‑Aldrich syndrome and a gene therapy applied as a topical gel for patients with dystrophic epidermolysis bullosa. These developments reflect the maturing pipeline of advanced therapies and precision‑medicine approaches.
The Rise of Biosimilars and Why It Matters
Another defining feature of 2025 was the record number of biosimilar recommendations: 41 approvals, the highest annual count to date. Biosimilars play a crucial role in expanding access, reducing systemwide healthcare costs and enabling competitive dynamics around longstanding biologics.
The year’s biosimilar momentum signals not only industrial maturity but also a stabilizing regulatory environment that supports predictable development pathways and fosters market confidence. It also reflects the EMA’s ongoing efforts to streamline evaluation while maintaining high scientific standards.
A More Sophisticated and Interconnected Regulatory Landscape
The 2025 figures also highlight the increasingly interconnected nature of regulatory oversight. The EMA’s annual report emphasizes its continued efforts to ensure ongoing monitoring of benefit-risk profiles, including label changes, safety warnings or, when necessary, suspension or withdrawal of medicines from the market.
This lifecycle‑oriented approach aligns with broader global trends: regulators are demanding deeper evidence, more robust data-sets and clearer governance mechanisms. As a result, successful innovation depends not only on scientific breakthroughs but equally on:
- regulatory foresight,
- strategic planning across the full product lifecycle,
- compliance with evolving data and safety requirements, and
- legal clarity in a rapidly shifting environment.
The data from 2025 underscores this reality: innovation succeeds when companies engage early, prepare for heightened scrutiny and build regulatory pathways that anticipate interoperability across jurisdictions.
What This Means for the Future of Medicines in Europe
Taken together, the 2025 outcomes point to an innovation ecosystem that is increasingly dynamic, but also increasingly complex. Novel therapies – whether for pulmonary disease, autoimmune conditions, metabolic disorders or postpartum depression – require interdisciplinary evidence generation, strong safety oversight and regulatory alignment between industry and authorities.
The EU’s regulatory system is evolving in ways that support this trajectory. The EMA’s coordinated approach strengthens patient access, ensures scientific consistency and prepares the ground for future regulatory initiatives, including those related to AI, advanced biologics and personalized medicine.
As the sector moves forward, companies that approach development with a holistic regulatory strategy will be best positioned to succeed.
DORDA’s Perspective: Supporting Innovation with Regulatory Clarity
For organizations active in pharmaceuticals, biotech, MedTech and digital health, the 2025 EMA data reinforces a clear message: innovation requires legal and regulatory excellence from the earliest development stages onward.
At DORDA’s Health & Life Science Group, we support clients across the entire lifecycle: from early development planning and clinical strategy to marketing authorization, reimbursement, post‑market obligations and ongoing compliance. Our work is grounded in the belief that responsible, well‑structured innovation is the key to ensuring that transformative treatments reach patients efficiently and safely.
This article was authored by Francine Brogyányi, Managing Partner at DORDA and Head of the Dedicated Industry Group Health & Life Science. She advises companies across pharma, biotech, MedTech and digital health on regulatory, compliance and strategic matters throughout the full product lifecycle, bringing deep expertise and practical insight to a sector that continues to evolve at remarkable speed.