Shilpa Medicare arm gets Morocco registration nod for Adalimumab
Hyderabad: Shilpa Medicare has announced that Shilpa Biologicals Pvt Ltd (SBPL), a wholly owned subsidiary of the Company 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.
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-α) 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.
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.
