Biocon and Viatris' Avastin biosimilar, Abevmy, receives EMA marketing authorization in Europe
Regulatory Milestone Achieved for European Market Entry
The European Medicines Agency (EMA) has granted final marketing authorization for Abevmy (ingredient: bevacizumab) from Biocon Biologics and Viatris. Abevmy is a biosimilar to Roche's Avastin, an original drug, and is a monoclonal antibody therapy that targets vascular endothelial growth factor-A (VEGF-A). This approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March 2021, demonstrating the companies' regulatory capabilities. This success highlights how the R&D expertise accumulated through their partnership has effectively overcome regulatory hurdles.
Equivalence Demonstrated Based on Phase 3 Clinical Data
This approval is based on the results of a global Phase 3 clinical study (Study MYL-1402O-3001) involving 671 patients with advanced non-squamous non-small cell lung cancer (nsNSCLC). At week 18 of the clinical trial, the objective response rate (ORR) was 41.5% in the Abevmy group and 43.1% in the original Avastin group, demonstrating statistical equivalence. The ratio of ORR between the two groups was 0.96 (90% CI: 0.83, 1.12), meeting the regulatory agency's equivalence criteria. No significant differences were observed in terms of safety and immunogenicity. This robust data will enhance the credibility of the drug among European healthcare professionals and patients, paving the way for rapid adoption.
Alleviating Healthcare Financial Burden and Expanding Patient Access
The original drug, Avastin, was a blockbuster drug with global peak sales of approximately $7.1 billion in 2019. However, with the expiration of its patent, the entry of affordable biosimilars like Abevmy is expected to significantly reduce the financial burden on the national health services (NHS) of European countries. The availability of a cost-competitive treatment option will expand opportunities for more patients with colorectal, lung, and breast cancer to receive early targeted cancer therapy. This aligns perfectly with the regulatory authorities' policy goals of promoting public health and driving down drug prices.
Intensifying European Biosimilar Competition
Currently, the European bevacizumab market is dominated by products from global pharmaceutical companies such as Amgen's Mvasi and Pfizer's Zirabev, making the entry barrier for Abevmy, a latecomer, relatively high. Therefore, Biocon and Viatris need to implement a differentiated commercialization strategy early on, focusing on establishing a stable local supply chain and accelerating the speed of reimbursement listing in each country. In particular, with Biocon's acquisition of Viatris' global biosimilar business in late 2022, the decision-making structure has been streamlined, which will be a driving force for responding flexibly to market changes. The success of building a direct sales network in Europe will be a key factor in determining Abevmy's long-term sales growth.
Abevmy's approval in Europe signals the start of intense market share competition with leading biosimilars such as Amgen's Mvasi and Pfizer's Zirabev in the Avastin market, which had global peak sales of $7.1 billion. Securing equivalence in objective response rate (ORR) compared to the original drug (41.5% vs. 43.1%) and demonstrating a favorable safety profile in a global Phase 3 clinical trial involving 671 patients are key clinical data points that will encourage European physicians to switch prescriptions. In the short term, negotiations with European national health authorities on drug pricing and the speed of reimbursement listing in each country will be critical factors in determining initial market penetration and sales volume. From a medium- to long-term perspective, the success of Biocon Biologics, which acquired Viatris' biosimilar business in 2022, in managing its global supply chain and direct sales distribution infrastructure will determine the success of maximizing product margins.
Source: EMA (ema)