Pfizer's HER2 Biosimilar, Trazimera, Receives Reaffirmation of Marketing Authorization Status from EMA
Pfizer Solidifies Position in HER2 Biosimilar Market
The European Medicines Agency (EMA) has reaffirmed the marketing authorization status of Trazimera (trastuzumab), Pfizer's HER2-targeting biosimilar, further solidifying its legal standing within Europe. Trazimera targets the human epidermal growth factor receptor 2 (HER2) protein, which is associated with poor prognosis in patients with breast and gastric cancer. This official announcement from the EMA confirms that the previously approved drug continues to fully comply with the stringent regulatory guidelines of the European Union (EU). This indicates that product quality control and communication with regulatory authorities have been maintained effectively even after commercialization.
Reference Product Herceptin's Patent Expiration and Market Restructuring
Trazimera's original drug, Herceptin, a blockbuster drug from Roche, was once a global standard of care with annual sales of approximately $7 billion. However, with the expiration of Herceptin's patent, the entry of biosimilars has disrupted the original developer's monopoly and shifted the market to a price competition model. Pfizer recognized this market shift and launched Trazimera at a lower price than the original drug, reducing the financial burden on healthcare systems and significantly improving patient access. As a result, the introduction of biosimilars in the oncology field has created a win-win situation for both patients and insurance finances.
Clinical Safety Demonstrated Through Continuous Regulatory Assessment
The report reflects the latest version of the European Public Assessment Report (EPAR), which has undergone 17 revisions, demonstrating the regulatory agency's thorough pharmacovigilance system. Since its initial approval on July 26, 2018, the EMA has continuously updated and monitored clinical data, and on March 20, 2023, it confirmed the indefinite extension of the marketing authorization. This long-term follow-up demonstrates that the biosimilar maintains complete biosimilarity in terms of efficacy and safety compared to the original drug. This provides clinicians and prescribing institutions with the confidence to continue prescribing without reservation.
Pfizer's Strategic Positioning in the Intensifying Global Biosimilar Competition
The global trastuzumab and biosimilar market is currently growing rapidly, reaching approximately $6.9 billion in 2025 and $8.86 billion in 2026. In this large market, Pfizer has strategically cultivated Trazimera as part of its oncology portfolio, along with other products such as AbbVie's Humira biosimilar. However, the market is crowded with competitive drugs such as Amgen's Kanjinti, Celltrion's Herzuma, and Samsung Bioepis' Ontruzant, leading to intense competition for market share. Pfizer is leveraging its global network and marketing capabilities to maximize formulary access and defend its market share.
With the global trastuzumab biosimilar market projected to reach $8.86 billion by 2026, Pfizer's Trazimera maintains its marketing authorization status from the EMA, securing a stable revenue base in Europe. As the reference product, Roche's Herceptin, previously held a $7 billion market share, intense competition for market share continues among competing pipelines such as Amgen's Kanjinti and Celltrion's Herzuma. The fact that regulatory uncertainties are completely controlled in a situation where clinical development and commercialization have been completed and the product is on the market is a key factor in increasing the stability of Pfizer's mid- to long-term healthcare revenue. This reaffirmation of approval status is significant in terms of commercial impact, as it provides an institutional basis for maintaining listing in formularies in major European countries and continuing to participate in public tenders.
Source: EMA (ema)