China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after Roche Holding AG’s (OTCMKTS: RHHBY) blockbuster Actemra/RoActemra (tocilizumab), has successfully passed review by the National Medical Products Administration (NMPA). This milestone positions Bio-Thera to enter a market dominated by Roche’s originator drug, which has been approved globally for multiple indications, including pediatric and systemic juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced cytokine release syndrome, and rheumatoid arthritis (RA).
Roche’s Actemra and Its Expanding Indications
Roche’s Actemra, an interleukin-6 receptor inhibitor, has been a cornerstone in treating various autoimmune and inflammatory conditions. Its mechanism of action involves suppressing the immune response by targeting the IL-6 receptor. The drug’s versatility was further highlighted when China’s health authorities included it in the 10th edition of the COVID-19 Infection Diagnosis and Treatment Plan, underscoring its potential in managing cytokine release syndrome associated with the virus.
Global Partnerships and Market Expansion
In April 2021, Switzerland-based Biogen Inc. (Nasdaq: BIIB) signed a deal with Bio-Thera to acquire development and commercialization rights for BAT1806 outside Greater China. This strategic partnership aims to leverage Biogen’s global reach to bring the biosimilar to markets in the US and EU, where the drug is currently under marketing review. The collaboration reflects growing interest in biosimilars as cost-effective alternatives to originator biologics.
Competitive Landscape in China
Bio-Thera’s success with BAT1806 comes amid a competitive environment in China, where several local players are developing their own biosimilar versions of tocilizumab. Companies such as Livzon Pharma, Qyuns Bio (QX003S), Mabpharm (CMAB806), and Hisun Pharma are actively pursuing biosimilar development, signaling a potential shift in market dynamics and increased competition for Roche’s Actemra in the region.-Fineline Info & Tech
