Viatris Receives EMA Approval for Teriflunomide, a Generic for Multiple Sclerosis
Viatris Inc. (VTRS) has secured final marketing authorization from the European Medicines Agency (EMA) on November 9, 2022, for Teriflunomide Viatris, a generic treatment for multiple sclerosis (MS). This approval follows the Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion on September 15, 2022. The generic demonstrated bioequivalence to the original Sanofi (SNY) Aubagio, offering a more affordable alternative to the high-cost originator drug.
Teriflunomide, an inhibitor of dihydroorotate dehydrogenase (DHODH), works by suppressing the proliferation of immune cells. Aubagio has demonstrated a 31% reduction in annualized relapse rate (ARR) and delayed brain atrophy progression in the TEMSO and TOWER Phase 3 clinical trials. Viatris successfully completed pharmacokinetic bioequivalence studies, bypassing the need for clinical trials, and leveraging Aubagio's clinical data to quickly establish a similar safety and efficacy profile.
The global MS market is projected to reach approximately $39 billion (approximately 54 trillion KRW) by 2030, driven by increasing prevalence and the introduction of innovative therapies. Aubagio generated global sales of 2.031 billion euros (approximately 2.139 billion USD) in 2022, just before its patent expiration. Viatris aims to rapidly capture market share in Europe by offering a cost-effective alternative and establishing a stable revenue stream.
Success in the European market hinges on the speed of individual pricing and reimbursement negotiations with national health authorities. Several oral generics, including Biogen's (BIIB) Tecfidera, have already entered the market, creating intense competition. Viatris must quickly finalize pricing negotiations in key countries such as Germany and France, based on cost-effectiveness data, to gain market share.
This approval further strengthens Viatris's transition towards a portfolio focused on high-value generics and biosimilars. The timely launch of generics upon patent expiration of chronic and rare disease treatments reduces patient healthcare costs and drives the company's long-term growth. Accumulated real-world data (RWD) and local partnerships are expected to solidify Viatris's position in the European market.
Viatris's (VTRS) EMA approval for its teriflunomide generic for multiple sclerosis will likely disrupt the European market for Sanofi's (SNY) Aubagio, which previously generated $2.139 billion in annual sales. For investors, a key financial consideration is whether Viatris can gain market share over competing generics in the global MS market, projected to reach $39 billion by 2030, and secure high-margin revenues. By using bioequivalence studies in lieu of large-scale Phase 3 trials, Viatris has significantly reduced R&D costs and lowered the barrier to entry in the DHODH inhibitor market. In the medium to long term, this approval is expected to lead to increased price competition with drugs like Biogen's Tecfidera, ultimately reducing healthcare costs and improving patient access to treatment for chronic diseases across Europe.