Julphar announced today that it reached a new milestone for the recombinant Insulin Glargine.
In collaboration with one of the leading biopharmaceutical R&D companies in Europe, Julphar succeeded indeveloping a qualified and well-characterized cell line for the production of Glargine. This was followed by further process development and optimization at pilot scale.
Julphar has reached a breakthrough by producing their 1st commercial scale batch in Julphar Diabetes, an advanced insulin facility. 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.
“We consider this project to be a turning point in the healthcare industry, enabling Julphar to acquire and implement a new concept of in-house research and development of recombinant therapeutic proteins”, said Dr. AymanSahli, CEO of Julphar. Dr. Sahli added: “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. 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. 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 USD 150 million plant for the production of Human Insulin crystals inaugurated in 2012, and a disposable insulin pen fill & finish facility.
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.