Qilu Pharmaceutical's Pregabalin Capsules Approved as First Domestic Product Passing Consistency Evaluation

By Baihuawen

On February 25, Qilu Pharmaceutical’s pregabalin capsules were approved for marketing in China, deemed to have passed the consistency evaluation, marking the first such approval in the country. To date, Qilu Pharmaceutical has had 25 drugs pass the consistency evaluation, 16 of which were the first in China.

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that blocks voltage-gated calcium channels, thereby reducing neurotransmitter release. It is clinically indicated primarily for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in adults, generalized anxiety disorder, neuropathic pain following spinal cord injury, and fibromyalgia.

The original manufacturer of pregabalin is Pfizer. It received approval from the European Union on July 5, 2004, and FDA approval on December 30 of the same year, under the brand name Lyrica. On May 21, 2010, Pfizer’s pregabalin capsules were approved for marketing in China for the treatment of postherpetic neuralgia, under the brand name Lyrica (Le Rui Ka). In 2019, due to the impact of generic drugs in the U.S. market, Lyrica’s sales declined by 33% to $3.321 billion, with sales in the U.S. market dropping by 44% to $2.012 billion.

In the domestic market, apart from the originator, Chongqing Saiwei Pharmaceutical is the only manufacturer producing and selling pregabalin capsules. Currently, Chongqing Saiwei Pharmaceutical has submitted an application for consistency evaluation of this drug. In addition, there are eight companies, including China Resources Double-Crane Pharmaceutical, CSPC Ouyi Pharmaceutical, and Nhwa Pharmaceutical, that have filed for production under the new Class 4 category. One company, Hongguan Biopharmaceutical, has filed for production under Class 5.2.