Lannett, a maker of generic pharmaceutical products, disclosed that it has been in talks with the Food and Drug Administration (FDA) about bringing a biosimilar version of insulin glargine into clinical trials.
March 22, 2020 marked the transition of new insulin agents from being considered a 351(a) biologic to a 351(k) biosimilar. Few manufacturers have publicly announced their intention to introduce biosimilar insulins. In fact, the most recent FDA decision on an insulin glargine agent was for Mylan and Biocon’s follow-on version, approved under the 505(b)2 pathway (under the 351[a] regulations).
According to Lannett, the company had a type II biosimilar biological product development meeting with the FDA last week. Tim Crew, Chief Executive Officer of Lannett reported that “FDA provided positive feedback on the clinical and [chemistry, manufacturing, and controls] advancement of our biosimilar insulin glargine that was consistent with our expectations. Our path forward is clear with regard to what is expected in the planned 351(k) biosimilar application, which we anticipate will be filed in calendar year 2022. We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA’s guidance.”
This biosimilar news release does have some missing interesting information. In December 2019, Lannett announced phase 1 clinical trial results, “with its strategic partner, the HEC Group of Companies.” Based on a Web search, the “HEC Group of Companies” seems to be a corporate recruitment firm. Another company, named the “H.E.C. Group Corporation” seems to be based in Osaka, Japan, and lists pharmaceutical development as one of its capabilities. Finally, a third company, located in China, is called “HEC Pharm,” and it is a distinct possibility. HEC Pharm does specify on its website that it has produced the active ingredient in insulin glargine.
Though not listed in the clinicaltrials.gov database, Lannett described the phase 1 trial as a single center, single-dose, double-blind, randomized, two-period crossover study comprising 27 healthy volunteers. Lannett claimed in its press release that the study met its objectives, comparing the pharmacokinetics and pharmacodynamics of this biosimilar candidate with US-licensed Lantus®, after a single subcutaneous dose.
Lannett has not disclosed what additional trials FDA believes will be needed to complete the submission package. However, based on an estimated submission date of late 2022, one may assume that additional human studies will be needed.
