New Phase I Clinical Trials for Two Proposed Ustekinumab Biosimilars

gloved hand withdraws drug solution with syringe

Over the last two weeks, NeuClone and Formycon announced updates regarding their respective ustekinumab biosimilars (reference product, Stelara).

On October 17, 2019, NeuClone announced that it has launched a Phase I clinical trial of its ustekinumab product, NeuLara.  NeuClone stated that the Phase I clinical trial is a “single-dose, double-blind, randomised, three-arm study [] being conducted across multiple Australian sites in over 200 healthy volunteers.”  The primary objective of the Phase I clinical trial “is to demonstrate equivalent pharmacokinetics (PK) and secondary objective is to demonstrate equivalent safety of NeuLara to US- and EU-sourced Stelara.”  NeuClone is developing NeuLara in partnership with the Serum Institute of India.

On October 28, 2019 Formycon announced that it has initiated a Phase I clinical trial to compare the pharmacokinetics, safety, and tolerability of its ustekinumab product, called FYB202, and Stelara.  Formycon further stated that “[p]rovided successful completion of clinical Phase I and subsequent Phase III testing and timely regulatory approval, FYB202 can be launched after patent expiry of Stelara (USA 09/2023; EU 07/2024).”  Formycon is developing FYB202 in a joint venture with Aristo Pharma GmbH.