EMA's CHMP Approval Momentum for Keytruda and Other Top Therapies: A Catalyst for Biotech Market Expansion in 2025

The European Medicines Agency (EMA) has emerged as a pivotal force in shaping the biotech investment landscape in 2025, with its Committee for Medicinal Products for Human Use (CHMP) accelerating approvals for groundbreaking therapies. Recent decisions, including Merck's KEYTRUDA (pembrolizumab) and a wave of novel treatments, underscore a strategic shift toward expanding access to innovative medicines while addressing unmet medical needs. For biotech investors, these developments signal both opportunities and risks in a rapidly evolving market.

Keytruda's Dual CHMP Approvals: A Strategic Expansion

Merck's KEYTRUDA, already a cornerstone of oncology, has received two positive CHMP opinions in September 2025, poised to redefine its market footprint. The first approval introduces a subcutaneous (SC) administration route for all adult indications, reducing infusion times to one or two minutes every three or six weeks, respectivelyMerck Receives Two Positive EU CHMP Opinions for KEYTRUDA^[1]. This convenience could drive adoption in outpatient settings and resource-constrained healthcare systems, broadening KEYTRUDA's accessibility. The second approval positions KEYTRUDA as the first perioperative anti-PD-1 therapy for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), based on the Phase 3 KEYNOTE-689 trialMerck Receives Two Positive EU CHMP Opinions for KEYTRUDA^[1]. By targeting earlier-stage disease, Merck is extending KEYTRUDA's lifecycle into a segment with high unmet demand, potentially capturing a significant share of the $5 billion head and neck cancer marketMeeting Highlights from the EMA CHMP (September 2025)^[2].

A Broader EMA Approval Landscape: Diversification and Affordability

Beyond KEYTRUDA, the EMA's September 2025 meeting highlighted a commitment to diversifying therapeutic options. Enflonsia (clesrovimab), a monoclonal antibody for respiratory syncytial virus (RSV) prevention in neonates and infants, and Imaavy (nipocalimab) for generalized myasthenia gravis, reflect a focus on niche but high-impact indicationsMerck Receives Two Positive EU CHMP Opinions for KEYTRUDA^[1]. Simultaneously, the approval of nine biosimilars, including Acvybra and Denosumab Intas, underscores the EMA's role in balancing innovation with cost containment. These biosimilars, targeting osteoporosis and autoimmune conditions, could reduce healthcare expenditures by up to 30% compared to originators, according to a report by the European CommissionEMA Marketing Authorization of New Drugs in May 2025^[3]. For investors, this duality—high-margin innovators and cost-effective biosimilars—presents a nuanced opportunity to hedge against pricing pressures while capitalizing on therapeutic advancements.

The Backlog Challenge: Bottlenecks and Anticipated Breakthroughs

Despite the EMA's momentum, a backlog of 112 drugs awaiting approval as of December 2024 remains a critical risk factor2025 Begins With 112 Drugs Waiting for Approval in Europe^[4]. Among these are linvoseltamab (a bispecific antibody for multiple myeloma) and blarcamesine (a candidate for early-stage Alzheimer's disease), both of which have generated significant investor buzz. While the EMA has prioritized high-complexity therapies, delays could disrupt market entry timelines and dilute competitive advantages for companies with strong pipelines. However, the agency's recent efficiency gains—such as streamlined conditional approvals for SpringWorks' mirdametinib in neurofibromatosis type 1—suggest a capacity to manage this backlog without compromising safety standardsEMA Marketing Authorization of New Drugs in May 2025^[3].

Investment Implications: Navigating the EMA's New Era

For biotech investors, the EMA's 2025 approval momentum offers three key takeaways:
1. Pipeline Diversification: Companies with therapies in high-priority areas (e.g., oncology, rare diseases) are better positioned to navigate regulatory bottlenecks. Merck's KEYTRUDA expansion and GSK's Blenrep approval for multiple myeloma exemplify this strategyMerck Receives Two Positive EU CHMP Opinions for KEYTRUDA^[1]EMA Marketing Authorization of New Drugs in May 2025^[3].
2. Biosimilar Synergy: Biosimilars remain a critical component of the EMA's affordability agenda, offering stable returns for firms like Novartis and Samsung Bioepis.
3. Risk Mitigation: Investors should monitor the EMA's backlog and prioritize companies with robust Phase 3 data and regulatory partnerships to expedite approvals.

In conclusion, the EMA's CHMP approvals in 2025 are not merely regulatory milestones but catalysts for market expansion. As KEYTRUDA's subcutaneous and perioperative indications move toward final authorization, and as the EMA continues to balance innovation with affordability, biotech investors must adopt a dual strategy: capitalizing on high-impact approvals while hedging against regulatory delays. The next quarter will be pivotal in determining whether these approvals translate into sustained growth or fleeting momentum.