Samsung Bioepis' Aybintio Receives Final Marketing Authorization from EMA for Avastin Biosimilar
EMA Final Approval and Entry into the European Market
Samsung Bioepis' bevacizumab biosimilar 'Aybintio (SB8)' has obtained final marketing authorization from the European Commission (EC). This achievement comes just two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), enabling commercial sales in 30 European countries. With this approval, Aybintio is officially listed as Samsung Bioepis' second approved oncology antibody biosimilar in Europe, following Ontruza.
Equivalence Proven in Global Phase 3 Clinical Trial of 763 Participants
The global Phase 3 clinical trial supporting this approval was conducted in 763 patients with metastatic or recurrent non-small cell lung cancer (NSCLC), administered in combination with paclitaxel and carboplatin. Based on the Per Protocol Set (PPS), the highest Objective Response Rate (ORR) was 50.1% for the Aybintio group compared to 44.8% for the original drug control group, meeting the pre-specified equivalence margin (0.737–1.357). The study also confirmed that the immunogenicity profile and adverse events typical of VEGF inhibitors, such as hypertension and asthenia, were at levels equivalent to the original drug.
70 Billion Dollar Blockbuster Avastin Market Strategy
Roche's 'Avastin,' the original drug, was a large-blockbuster targeted anticancer drug with annual global sales reaching approximately $7.1 billion (about 7.07 billion Swiss francs). After the expiration of Avastin's European material patents, price competition intensified as Abvitio secured approval for extrapolation across Avastin's key indications, including colorectal cancer, breast cancer, renal cell carcinoma, ovarian cancer, and cervical cancer. This has served as a pivotal opportunity to significantly alleviate the financial burden on public health authorities across European countries and to dramatically improve access to high-cost biologic therapies for patients with severe cancers.
Competition with Amgen and Pfizer and Utilization of Biogen's Distribution Network
The European bevacizumab market is a battleground where Amgen's 'Mvasi' and Pfizer's 'Zirabev' have already entered and are engaged in preemptive competition. Samsung Bioepis has promptly entered the national tender markets through the established local distribution network of its global partner, Biogen (BIIB). The company is positioned to expand its market share using its price competitiveness and stable supply chain as weapons in a market previously dominated by large multinational pharmaceutical companies.
Diversification of Oncology Biosimilar Portfolio and Growth Drivers
The European commercialization of Aybintio serves as a stepping stone to elevate the global standing of its parent company, Samsung Biologics (KRX: 207940), and Samsung Bioepis. By successfully expanding its product portfolio from a focus on autoimmune diseases into the high-value oncology domain, the company has diversified its cash flow. Passing the strict review standards of global regulatory authorities also provides powerful momentum for the commercialization of subsequent pipelines.
Samsung Bioepis' EMA marketing authorization for Aybintio (SB8) marks a commercial turning point, initiating full-scale competition with Amgen's Mvasi and Pfizer's Zirabev in the $7.1 billion annual original Avastin market. The proven equivalence in ORR (50.1% vs 44.8%) and safety data from the global Phase 3 trial involving 763 NSCLC patients will serve as a key clinical competitive advantage in national drug tender competitions across Europe. Based on the robust sales network of its local partner, Biogen (BIIB), rapid market share acquisition is likely in the short term. In the long term, it will drive significant price reductions for the original drug and expand biosimilar prescriptions. From an R&D perspective, the approval of extrapolation to other indications, such as colorectal cancer, based on non-small cell lung cancer (NSCLC) clinical data reaffirmed the regulatory completeness of biosimilar development capabilities. From an investment perspective, adding high-margin oncology pipelines to the consolidated results of parent company Samsung Biologics (KRX: 207940) serves as a catalyst for stably diversifying its product portfolio, which has been heavily concentrated in autoimmune diseases.
Source: EMA (ema)