Julphar successfully concludes Phase I clinical trial of its biosimilar human insulin
Julphar today announced its Phase 1 clinical data that demonstrated similarity of its investigational biosimilar human insulin compared to the EU-licensed reference product, Eli Lilly HUMINSULIN®.
All comparability studies showed biosimilarity of Julphar’s insulin in comparison with the reference product, Huminsulin®. The outcome of the phase I clinical trial confirmed these results, showing bio-equivalence of Julphar Insulin to Huminsulin®. Julphar's trial met its key endpoints, showing comparative and equivalent pharmacokinetics and pharmacodynamics for the reference product. Besides showing equivalent PK/PD, in addition and as a secondary endpoint the trial showed no difference in safety between the two drugs.
“The approval of this study by the German BfArM, and its successful conclusion is an important step for Julphar’s biosimilars program," said Dr. Ayman Sahli, CEO, Julphar. "This makes JULPHAR the first company in the Middle East to have clinical trial filing accepted under the EMA biosimilar guidelines.
Sahli added: “biosimilars can play an important role in broadening access to high-quality biologics and optimistic that the savings generated through the use of biosimilars can be used to fund other unmet medical needs. We have already made inroads into the biosimilars segment to produce sufficient insulin for the region at affordable cost. Julphar Diabetes, the 11th plant of Julphar has already set up for manufacturing and commercializing diabetes products, including 1,500 kg of Human Insulin crystals.”
“We are committed to building on our success with biosimilars by making affordable, safe and effective products available to GCC/MENA patients and healthcare providers”, further elaborated Sahli.
*The abstract of the study results will be published online under European Clinical Trials Database; EudraCT-No. 2014-001562-97 with Trial ID INSULCT001.