From Morocco, MoH
Shilpa Biologicals (SBPL), a wholly owned subsidiary of Shilpa Medicare has received registration approval for Adalimumab from Morocco, MoH. This is the first Biosimilar approval from any international market for high concentration Adalimumab developed by SBPL.Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL). Adalimumab contains Adalimumab as an active ingredient. Adalimumab is a fully human monoclonal IgG1 antibody produced recombinantly by Chinese Hamster Ovary (CHO)cells. Adalimumab consists of 1330 amino acid containing glycoprotein which has two copies of heavy- and two copies of light-chains in heterodimeric form with a molecular weight of 148 kDa (approx.). Adalimumab binds specifically to Tumor Necrosis Factor-alpha (TNF- and blocks its interaction with the p55 and p75 cell surface TNF receptor. Adalimumab is indicated for Rheumatoid Arthritis (RA) in adults.
The Adalimumab 40 mg/ 0.4 mL Solution for Injection is highly similar to the innovator (Humira) with respect to Quality, Safety and Efficacy.
SBPL has aggressively submitted its Adalimumab dossier in more than 15 emerging markets countries and is in the process of submitting the dossier to other countries as well.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
