The Searle Company Limited has obtained regulatory approval from the Drug Regulatory Authority of Pakistan (DRAP) for its biosimilar Denosumab injections in 60mg and 120mg doses.
The pharma company shared this information with the Pakistan Stock Exchange (PSX) through a notice on Monday in accordance with Section 96 of the Securities Act, 2015 and Clause 5.6.1(a) of the Rule Book of the PSX.
“It is hereby informed that the Company has successfully obtained registration of Denosumab injections 120mg and 60mg (biosimilar drugs) from the Drug Regulatory Authority of Pakistan,” read Searle Company’s notice.
Under a licensing agreement with Mabwell Pharmaceuticals, China, Searle holds the rights to market and sell these injections in Pakistan. The 60mg dose is indicated for managing osteoporosis, while the 120mg dose is intended for oncology care.
The company is now preparing for the commercial launch, marking a key step in expanding its product portfolio. Searle said the development underscores its commitment to strengthening its business, enhancing earnings quality, and creating greater value for shareholders.