Shots:

• The P-I clinical trial involves assessing of a single dose of either NeuLara- US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study
• Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs- CI (90%) of the GMR within the pre-specified (80%-125%) acceptance limits for all 3 pairwise comparisons. Additionally- the safety- immunogenicity and tolerability profiles were similar in all three treatment arms
• NeuLara is a biosimilar referencing Stelara- being developed to treat patients with PsO- PsA- CD and UC. The biosimilar is being co-developed by NeuClone and its strategic manufacturing partner- Serum Institute of India

 ­ Ref: Neuclone | Image: Business Wire