NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

 NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

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

Click here ­to­ read full press release/ article | Ref: Neuclone | Image: Business Wire

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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