Bio-Thera Solutions Ltd (SHA: 688177) announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Usymro, a biosimilar version of Johnson & Johnson’s Stelara (ustekinumab). The approval covers adult patients with moderate‑to‑severe plaque psoriasis (PsO), active psoriatic arthritis (PsA), and moderately‑to‑severely active Crohn’s disease (CD)—marking Bio-Thera’s UK market entry following US and EU approvals in 2024.
Regulatory Milestone
Item
Detail
Company
Bio-Thera Solutions Ltd (SHA: 688177)
Product
Usymro (ustekinumab biosimilar)
Reference Product
Stelara (J&J) – IL‑12/23 inhibitor
Regulatory Body
UK MHRA
Approval Date
March 2026
Indications
PsO, PsA, CD (adults)
Prior Approvals
US (May 2024), EU (Aug 2024)
China Status
NMPA filing under review
Commercial Partnership – Gedeon Richter
Parameter
Detail
Partner
Gedeon Richter
Agreement Date
October 2024
Bio-Thera Responsibilities
R&D, manufacturing, commercial supply
Gedeon Richter Territory
EU, UK, Switzerland, Australia, select European countries
Gedeon Richter Role
Commercialization
Strategic Implications
Global Biosimilar Expansion:US + EU + UK approvals establish Bio-Thera as a tier‑one global biosimilar developer, capable of regulatory navigation across major pharmaceutical markets—a significant achievement for Chinese biopharma.
Stelara Market Opportunity: Stelara generated ~ $10 billion globally in 2024; patent expiry creates $3‑4 billion biosimilar opportunity; Usymro’s early mover advantage in UK/EU positions for market share capture.
Gedeon Richter Synergy: The established European commercial partnership leverages Richter’s dermatology and gastroenterology sales infrastructure, avoiding proprietary build‑out costs and accelerating revenue generation.
China Market Pending:NMPA review underway; domestic approval would enable China launch and potential cost advantage in the world’s second‑largest pharmaceutical market.
Forward‑Looking Statements This brief contains forward‑looking statements regarding UK commercial launch timelines, EU market penetration, and NMPA approval outcomes for Usymro. Actual results may differ due to risks including competitive Stelara biosimilar launches, pricing pressure in European tenders, and manufacturing capacity constraints.-Fineline Info & Tech
By Fineline Cube