EMA Recommends Approval for 104 New Medicines, Including Madrigal's Rezdiffra, Marking a Regulatory Milestone for the European Market
Record Number of Approvals and the Rise of Biosimilars
The European Medicines Agency (EMA) announced in its 2025 annual report that it has recommended marketing authorization for 104 medicines for human use and 30 medicines for veterinary use. Among these, a record 41 biosimilars, which are intended to replace blockbuster original medicines nearing patent expiration, were recommended for approval, demonstrating the strong commitment of European health authorities to cost control. These regulatory changes aim to alleviate the financial burden on European healthcare systems and improve patient access to medicines. While this may put pressure on the pricing of existing original drugs, it presents an opportunity for follow-on biosimilar companies to quickly gain market share in Europe.
MASH and the Launch of the First Innovative Treatment for a Rare Disease
The report highlighted several first-in-class innovative new drugs approved for diseases that previously had no treatment options, attracting significant market attention. Madrigal Pharmaceuticals' (MDGL) Rezdiffra (active ingredient: resmetirom, a THR-Ξ² agonist) for the treatment of metabolic dysfunction-related steatohepatitis (MASH) received conditional marketing authorization from the European Commission (EC) on August 19, 2025, securing its position as the first approved therapy in this category. Additionally, Insmed's (INSM) Brinsupri (active ingredient: brensocatib, a DPP1 inhibitor) for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) received final approval on November 18, 2025, after going through the PRIME and accelerated assessment pathways. These drugs are expected to address significant unmet medical needs and achieve strong commercial success in the long term.
Gene Therapies for Rare Diseases and M&A Successes
The EMA recommended approval for a total of 16 orphan medicines, strongly supporting the commercialization of advanced therapy medicinal products (ATMPs). Sanofi (SNY) acquired Provention Bio for $2.9 billion in 2023, securing Teizeild (active ingredient: teplizumab, a CD3-targeted monoclonal antibody) for the treatment of type 1 diabetes (T1D), which received approval on January 8, 2026. Furthermore, Waskyra (active ingredient: etuvaptagene autotemcel), a gene therapy for Wiskott-Aldrich syndrome (WAS) led by the Italian non-profit research foundation Fondazione Telethon, also received final approval on January 9, 2026. These are prime examples of the success of big pharma's mergers and acquisitions (M&A) strategy and the development of ultra-rare disease treatments led by non-profit organizations.
Animal Vaccines and Enhanced Emergency Response from a One Health Perspective
In addition to human medicines, 30 veterinary medicines were also recommended for approval, marking the second consecutive year of record-high recommendations. Among these, 13 are new active substances, and 16 are vaccine products for the prevention of livestock infectious diseases. In particular, to respond quickly to the spread of serious livestock infectious diseases such as bluetongue virus, seven vaccines were authorized through the exceptional circumstances pathway. These measures demonstrate the regulatory authorities' rapid crisis response capabilities under the One Health principle, which recognizes the close connection between human and animal health, to protect national food security and prevent economic losses for farmers.
The European Commission's conditional approval of Rezdiffra is expected to accelerate short-term revenue growth by capitalizing on the first-mover advantage in the MASH treatment market, which is projected to grow rapidly to $33.8 billion by 2030. However, it is necessary to develop a marketing strategy that anticipates the market entry of competing drugs in the GLP-1 class, such as Novo Nordisk's Wegovy, which have demonstrated strong Phase 3 clinical data. Brinsupri, which received European approval based on the results of the ASPEN Phase 3 trial, is expected to achieve blockbuster status with annual revenues exceeding $1 billion, so domestic and international pipeline developers should use the speed of commercialization of this first-in-class drug as a benchmark. The success stories of Teizeild and Waskyra, which utilized diversified regulatory pathways such as orphan drug designation and the PRIME scheme, suggest that it is essential to incorporate early-stage companion diagnostic biomarkers and accelerated approval pathways into the design from the initial clinical stages. In conclusion, this EMA annual report reflects the dual and dynamic regulatory approach of European healthcare authorities, which aims to rapidly introduce high-priced new drugs while ensuring affordability through the approval of 41 biosimilars.