Searle gets DRAP nod for Pakistan’s first locally manufactured Monoclonal antibody

Searle Company Limited (SEARL) has earned approval from the Drug Regulatory Authority of Pakistan (DRAP) for ADALIMUMAB, the first locally manufactured Monoclonal antibody (mABs) in Pakistan.

The company announced the development in its notice to the Pakistan Stock Exchange (PSX) on Thursday.

“We are pleased to share that SEARL has received approval from the DRAP for ADALIMUMAB, a biosimilar drug developed in collaboration with BioRay Biopharmaceuticals Co. Limited, China, this marks the first locally manufactured Monoclonal antibody (mABs) in Pakistan,” read the notice.

It is pertinent to inform that mABs are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance, modify or mimic the immune system’s attack on cells that are not wanted, such as cancer cells.

“The introduction of ADALIMUMAB to the market within the next 3-6 months is a strategic move aimed at providing high-quality, affordable biotechnology medicines to patients in Pakistan,” the pharmaceutical company shared.

“This development aligns with our commitment to diversifying our product portfolio, thereby enhancing the quality of earnings and shareholders’ value,” it added.

Earlier in September, SEARL announced that it has earned approval from the UAE ministry, and registered its manufacturing facility in the Middle Eastern country.

The company back then informed that it was expanding rapidly in several regions of the world including South Asia, Southeast Asia, Africa, Francophone Africa, GCC, Commonwealth of Independent States (CIS), Canada, Europe and Latin America (EU&LATAM) etc.