Singapore, Sept. 5 -- Mabwell, a China-based biopharmaceutical company, andPakistan'sThe Searle Company have jointly announced that two denosumab products, 9MW0311 and 9MW0321, have received marketing authorisation from Drug Regulatory Authority of Pakistan(DRAP).

This marks bothPakistan'sfirst regulatory approval for a denosumab biosimilar and Mabwell's first overseas marketing authorisation for its products.

9MW0311 is a recombinant fully humanizedanti-RANKL monoclonal antibody injection (60mg), developed as a Prolia(R) biosimilar. OnMarch 28, 2023, the marketing application for 9MW0311 was approved by the National Medical Products Administration (NMPA) for the treatment of postmenopausal women with osteoporosis at high risk of fractu...