Ras Al Khaimah: Julphar pharmaceutical company, based in Ras Al Khaimah, has managed to produce the first ever long acting man-made version of human insulin, known recombinant Insulin Glargine, in the region.
According to a top official, the new milestone is the fruit of collaboration with one of the leading biopharmaceutical R&D companies in Europe.
Dr Ayman Sahli, CEO of Julphar, on Tuesday said they succeeded in developing a qualified and well-characterized cell line for the production of Glargine. “This was followed by further process development and optimization at pilot scale.”
Insulin Glargine is a basal insulin analogue, given once daily to help control the blood sugar level of diabetics. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours.
Julphar has reached a breakthrough by producing their 1st commercial scale batch in Julphar Diabetes, an advanced insulin facility, Dr Sahli added.
Dr Ayman Sahli, CEO Julphar
“The company is already planning the next phases of this advancement including stability, comparability, pre-clinical and clinical studies in its endeavor of developing Insulin Glargine, as a biosimilar to Lantus.”
Dr Sahli stated that the project, a turning point in the healthcare industry, enables Julphar to acquire and implement a new concept of in-house research and development of recombinant therapeutic proteins.
“This exciting development comes as a natural expansion and builds upon Julphar’s strong platform in diabetes healthcare.”
Biosimilar insulins can play an important role in broadening the access to high quality biologics, he elaborated. “The savings generated through the use of biosimilars can be used to fund other unmet medical needs.”
Julphar has already made inroads into the biosimilars segment to produce sufficient insulin for the region at affordable cost, Dr Sahli noted. “The Julphar Diabetes plant is already set up for manufacturing and commercializing diabetes products, including 1,500 kg of Human Insulin & Insulin Analogues.”
This evolution is inclusive of a US$150 million plant for the production of human insulin crystals inaugurated in 2012, along with a disposable insulin pen fill & finish facility, he elaborated.
“Julphar is committed to building on its success with human insulin by making affordable, safe and effective insulin analogues available to GCC/MENA patients and healthcare providers.”