Quanticate supported a biopharmaceutical company across the full remit of clinical data services for the development of a new biosimilar. The Sponsor was seeking a provider that could offer full service support across the biometric functions and wanted to benefit from the efficiencies gained by centralizing their Clinical Data Management (CDM), Statistical Programming, Medical Writing (MW) and Pharmacovigilance (PV) activities to a single service provider.
The clinical studies Quanticate worked on were part of a development programme aiming to license a biosimilar for the treatment of a series of inflammatory conditions. The series of studies actively tested the proposed biosimilar in healthy volunteers and patients with rheumatoid arthritis (RA). However, extension of use for other inflammatory conditions such as psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and juvenile idiopathic arthritis was subsequently sought. The Statistical Programming and PV teams provided support for a further 2‑3 clinical studies in the clinical development programme.
Each of the studies presented their own unique challenges which were resolved by Quanticate and resulted in the approval of the proposed biosimilar by the European Medicines Agency (EMA).
Quanticate provided CDM services across the Phase 3 studies.
Some of the challenges faced by the CDM team are detailed below.
Quanticate provided Statistical Programming support to the Sponsor for the Phase 1 and Phase 3 studies.
Support for the Phase 1 studies was requested as PK analysis in biosimilar studies is a standard requirement to demonstrate the effectiveness of the potential biosimilar vs. the existing approved drug.
Quanticate provided PV support on the Phase 1 and Phase 3 studies.
Quanticate’s medical writers provided support on the Phase 1 study, the Phase 3 studies and the EMA submission which was successfully accepted.
In addition to supporting the Sponsor with their development of a biosimilar, Quanticate has also supported the client with their development of a second biosimilar (for oncology).
Quanticate worked extensively with the Sponsor from the start of their clinical programme and after several years of support and a good relationship, the Sponsor was able to achieve their goal of having their proposed biosimilar successfully approved by the EMA. Following successful EMA approval, the Sponsor is planning submissions in other regions.