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.
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