Henlius wins first overseas approval for adalimumab biosimilar in Pakistan

Henlius said its partner Getz Pharma received DRAP registration in Pakistan for HANDAYUAN, marketed locally as Adaliget, marking the biosimilar's first approval outside China. The clearance opens the door to launches across 11 markets and gives Henlius another regulatory milestone in its push to expand beyond its home market.

Why it matters: - Pakistan becomes the first overseas market to approve HANDAYUAN, Henlius’ self-developed adalimumab biosimilar. - The approval expands Henlius’ global biosimilar footprint and adds to its push to commercialize products beyond China. - Adalimumab is a major autoimmune medicine with broad global use, but access remains limited in many emerging markets.

What happened: - Henlius said its partner Getz Pharma received registration certificates from the Drug Regulatory Authority of Pakistan for HANDAYUAN. - The product is marketed in Pakistan under the brand name Adaliget. - The approval covers all indications of the reference adalimumab product approved in Pakistan. - The clearance is HANDAYUAN’s first international approval and Henlius’ eighth self-developed product to secure marketing authorization outside China.

The details: - HANDAYUAN is the first self-developed Henlius product approved for autoimmune disease treatment. - China’s National Medical Products Administration approved HANDAYUAN in December 2020. - Fosun Wanbang handles domestic commercialization of HANDAYUAN in China. - HANDAYUAN was included in China’s National Essential Medicines List in July 2026. - DRAP’s review relied mainly on the data package Henlius originally submitted to the NMPA. - Henlius said it completed analytical characterization, non-clinical studies and clinical trials comparing HANDAYUAN with reference adalimumab. - The company said the dataset showed HANDAYUAN was highly similar to the reference product in quality, safety and efficacy. - HANDAYUAN is the first adalimumab biosimilar evaluated in a Phase 3 trial enrolling Chinese patients with psoriasis. - Henlius said the product’s production site and quality management system meet international standards. - Henlius said its manufacturing network has passed about 100 regulatory inspections and audits by regulators and partners including the NMPA, EMA, FDA, PIC/S members Indonesia BPOM and Brazil ANVISA, EU Qualified Persons and global commercial partners. - The product joins Henlius’ ex-China portfolio, which includes HANQUYOU, HANSIZHUANG, Poherdy and HANBEITAI. - Henlius and Getz Pharma signed a licensing and supply agreement in 2022. - Under that deal, Getz Pharma plans to roll out Adaliget across 11 emerging markets in Asia, Africa and Europe. - Pakistan is the first market to clear the partnership.

Between the lines: - The Pakistan approval shows Henlius is using one regulatory package to pursue broader market access across multiple countries. - The company is leaning on existing clinical and quality data to speed review in markets outside China. - The result also strengthens Getz Pharma’s role as a launch partner for Henlius’ biosimilar lineup.

What's next: - Henlius said it will keep working with Getz Pharma and other partners on more regulatory submissions and product launches. - The companies are expected to pursue additional biologics across international markets under their broader collaboration. - Henlius said it will continue maintaining international quality benchmarks as it expands overseas.