Qilu Pharmaceutical's Exemestane Tablets Become First in China to Pass Consistency Evaluation

By Baihuawen

On May 25, Qilu Pharmaceutical's Exemestane Tablets passed the consistency evaluation, becoming the first in China.

Exemestane is an aromatase inhibitor developed by Pfizer, clinically used primarily for: 1) adjuvant treatment of early invasive breast cancer in postmenopausal women with estrogen receptor-positive tumors, following 2–3 years of tamoxifen adjuvant therapy, to complete a total of 5 years of adjuvant endocrine therapy; and 2) treatment of advanced breast cancer in naturally or artificially postmenopausal women whose disease has progressed after tamoxifen therapy.

Manufacturers producing and selling exemestane tablets in the Chinese market include Pfizer, Qilu Pharmaceutical, and Zhejiang Medicine; however, no company has yet passed the consistency evaluation for this drug. Qilu Pharmaceutical’s exemestane tablets were approved for marketing in 2002, and a supplemental application for consistency evaluation was submitted in May 2019.