Clinical Trial Announcements

This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics.

On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in Phase 3 clinical trials.  The SPAs cover the protocols for three registration clinical trials.  One registration clinical trial is for the treatment of branch retinal vein occlusion and the remaining two are for diabetic macular edema. Outlook plans to initiate the additional clinical trials in 2020.

On December 4, Bio-Thera Solutions announced that the China National Medical Products Administration (“NMPA”) approved its Investigational New Drug (“IND”) application for BAT2206, a proposed biosimilar of STELARA (ustekinumab).  Bio-Thera will be conducting a clinical study to compare the pharmacokinetics and safety of BAT2206 with that of STELARA sourced from the US and EU.

Also on December 4, Lannett announced results from human clinical trials of its proposed insulin glargine biosimilar. The clinical trial assessed the pharmacokinetics, pharmacodynamics, and safety profile of the proposed insulin glargine biosimilar after a single subcutaneous dose compared to its reference product, LANTUS.  Lannett reported that the study results met all primary endpoints.

Today, NeuClone announced Phase 1 clinical results for NeuCeptin, its proposed biosimilar of HERCEPTIN (trastuzumab). According to NeuClone, the biosimilar candidate met all primary and secondary endpoints in the trial, including all pre-specified criteria demonstrating clinical pharmacokinetic similarity compared to US- and EU-sourced reference product, and the safety and tolerability profiles were equivalent between all three treatment arms.