Anjiarun (adalimumab biosimilar) / Sinocelltech - LARVOL DELTA

A randomized, double-blind phase III study to demonstrate the clinical similarity of biosimilar SCT630 to reference adalimumab in Chinese patients with moderate to severe plaque psoriasis. (PubMed, Int Immunopharmacol) - "This phase III study demonstrated the equivalences in efficacy, safety and immunogenicity of SCT630 to adalimumab in patients with moderate to severe psoriasis."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Phase I, randomized, double-blind, single-dose study to assess the pharmacokinetics, safety, and immunogenicity of the proposed biosimilar SCT630 and adalimumab in healthy Chinese subjects. (PubMed, Int Immunopharmacol) - "SCT630 was well tolerated and demonstrated PK and safety profiles similar to adalimumab. The profiles support the initiation of further confirmatory study to demonstrate the clinical similarity of SCT630 to adalimumab."

Clinical • Journal • PK/PD data

Pharmacokinetics and Safety in Healthy Volunteers (clinicaltrials.gov) - P1; N=146; Completed; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion

The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis (clinicaltrials.gov) - P3; N=330; Active, not recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Dermatology • Immunology • Psoriasis

4 questions about the expected increase in biosimilars for IBD (Consultant360) - "Adam Cheifetz, MD...spoke with Gastroenterology Consultant about biosimilars following his presentation on the topic at the Advances in Inflammatory Bowel Diseases Regional Meeting in Boston, Massachusetts...Adam Cheifetz: I think other companies are interested in bringing more biosimilars to market....If they are not going to do proactive TDM with infliximab (and likely adalimumab), physicians should be using a combination immunomodulator (azathioprine or methotrexate) to increase drug concentrations and decrease immunogenicity, similar to the Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease (SONIC) trial."

Media quote

Newly added product (clinicaltrials.gov) - P3, Biosimilar, Psoriasis

Pipeline update