DRAP approves Pakistan’s first insulin glargine biosimilar

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has approved the insulin glargine cartridge developed by China’s Gan & Lee Pharmaceuticals, marking the first biosimilar of its kind to receive official clearance in the country.

According to China Economic Net (CEN), the approval is expected to significantly improve access to modern glucose-lowering therapies in Pakistan, where diabetes poses a severe public health challenge. The country currently has the highest prevalence of diabetes in the world, with an estimated 34.5 million adults (aged 20–79) living with the condition — a prevalence rate of 31.4%.

Gan & Lee highlighted that 80% of Pakistan’s insulin needs are currently met with second-generation human insulin. By contrast, insulin glargine — a third-generation, long-acting insulin — offers more stable 24-hour glycemic control through a single daily injection, better mimicking the body’s natural basal insulin levels.

“This provides patients with a safer and more convenient long-term treatment option,” the company told CEN.

In 2022, Gan & Lee also introduced a pre-filled insulin glargine pen in Pakistan, marking the first biosimilar of its type in the country. The newly approved cartridge further strengthens its presence in the local market.

Gan & Lee emphasized the complementary strengths of China and Pakistan in the pharmaceutical sector. China’s capabilities in biopharmaceutical innovation and large-scale production align with Pakistan’s high medical demand, cost-effective labor, and established generic drug manufacturing ecosystem.

“We are working closely with leading Pakistani pharmaceutical firms on technology transfer and localized manufacturing. For example, the filling of insulin glargine vials has already been localized,” the company stated.

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