Clinical trial development planning

Biosimilar clinical development plans differ significantly from originator programs. Although these trials follow many of the same international regulatory guidelines as their reference biologics, regulatory requirements worldwide continue to be established in this developing landscape. These guidances may be clear, or very often, open to interpretation. They may differ from region-to-region, from country-to-country, locally, or even from site-to-site, making successful execution of biosimilars clinical trials extremely complicated. Additionally, biosimilars and originator molecules themselves, including procurement, handling, storage, import/export requirements, preparation and administration to patients all require specialised knowledge and heightened attention. Therefore, Sponsor assessment of their clinical development partner mandates that the CRO partner has;

Demonstrated biosimilars depth and breadth of experience with protocol development
Successful execution of pharmacokinetic sub-studies (pkss) and clinical comparative studies (ccs)
The right therapeutic expertise
Regulatory knowledge and intelligence
Global reach
Feasibility and site id strategies
Staff expertise to drive to a successful outcome

Worth noting, biosimilar studies are specifically designed to demonstrate equivalence for not only safety and efficacy but for analytical results of pharmacokinetic and other clinical lab data. These data serve to confirm appropriate patients randomised in the clinical trial, as well as a key primary endpoint in interim and final study analyses. Often biosimilars trials require multiple laboratories: central, bioanalytical and specialty laboratories. With laboratory service offerings and knowledge of in country and global requirements, ICON offers you a streamlined pathway to manage these critical laboratory samples. In addition to meeting the rigors of precise testing requirements, ICON recognises that precise end-to-end sample tracking and management is paramount, from bedside to clinical results. We ensure that every ICON team member, ancillary service provider, third party vendor and site personnel are all fully aligned on protocol requirements and patient visit schedules. Automated tracking systems, agnostic of laboratory kit development, accessioning practices and barcodes are a service offering ICON can provide eliminating the need for manual tracking, transcription errors and lost or mishandled samples throughout the course of study conduct.

Regulatory requirements and restrictions also vary globally, necessitating careful consideration of international differences, in-country laboratory capabilities, and robust sample management. Failure to address these aspects at the study’s outset can lead to major setbacks, including site or country exclusion, delays, compromised data quality, increased costs, or even risk to trial outcomes and product approval.

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