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First Biosimilar Insulin Glargine Approved in Pakistan to Address Diabetes Crisis

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May 23, 2025
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Gan & Lee Pharmaceuticals has secured the inaugural biosimilar approval for its insulin glargine cartridge from Pakistan’s Drug Regulatory Authority (DRAP), marking a pivotal step toward expanding access to advanced diabetes treatments nationwide. Reports indicate this authorization could significantly improve the availability of glucose-lowering therapies in a country grappling with one of the world’s highest diabetes burdens.

Recent data reveals Pakistan has approximately 34.5 million diabetic patients aged 20–79, representing a staggering 31.4% prevalence rate—the highest globally. “Over 80% of Pakistan’s insulin supply currently depends on second-generation human insulin,” stated a representative from Gan & Lee. “As a third-generation insulin, glargine closely mimics physiological basal insulin secretion, enabling stable 24-hour glycemic control with a single daily injection. This innovation offers patients a safer, more convenient long-term management solution.”

The newly approved cartridge follows Gan & Lee’s 2022 introduction of its insulin glargine pre-filled pen, Pakistan’s first biosimilar glargine product. The company emphasized the synergy between Chinese and Pakistani pharmaceutical sectors, noting China’s strengths in biopharmaceutical research, mass production, and supply chain efficiency, paired with Pakistan’s high demand for diabetes care, robust generic drug infrastructure, and cost-effective labor.

“Collaboration with Pakistani pharmaceutical leaders has included technology transfers and localized manufacturing initiatives,” Gan & Lee explained. “For example, insulin glargine vial filling is now being produced locally, enhancing sustainability and accessibility.” This partnership aims to address critical healthcare gaps while fostering bilateral economic growth in the pharmaceutical industry.

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