Henlius receives Pakistan approval for adalimumab biosimilar HANDAYUAN
Henlius has received approval in Pakistan for HANDAYUAN, its adalimumab biosimilar, marking the product's first regulatory approval outside China.
The biosimilar, marketed locally as Adaliget, has been approved by Pakistan's Drug Regulatory Authority across the indications authorised for the reference adalimumab product in the country.
The approval advances Henlius' international biosimilar strategy and expands access to an established TNF inhibitor used across multiple inflammatory and autoimmune diseases.
Field | Content |
Alert Type | Approval |
Drug Name | Adalimumab biosimilar |
Brand Name | HANDAYUAN / Adaliget |
Company | Henlius |
Regulatory Authority | Drug Regulatory Authority of Pakistan |
Approval Type | Marketing approval |
Reference Product | Adalimumab reference biologic |
Indication | All indications of the reference adalimumab product approved in Pakistan |
Therapy Area(s) | Immunology; inflammatory disease; autoimmune disease |
Technology or Modality | Biosimilar monoclonal antibody; TNF inhibitor |
Geography | Pakistan |
What Happened | Pakistan's Drug Regulatory Authority approved Henlius' adalimumab biosimilar HANDAYUAN, marketed locally as Adaliget. |
Why It Matters | The decision is HANDAYUAN's first approval outside China and expands Henlius' international commercial footprint in biosimilars. |
Supporting Context | Adalimumab is a TNF-targeting monoclonal antibody used across a wide range of inflammatory and autoimmune diseases. |
Key Takeaway | Henlius has secured the first overseas approval for HANDAYUAN with regulatory clearance in Pakistan. |
What to Watch | Commercial launch in Pakistan and additional international regulatory filings and approvals for HANDAYUAN. |
Primary Source | Henlius |
Relevant Date | 16 September 2026 |
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