CMC and local regulatory expertise deliver timely anti-cancer drug approval

An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration. The Sponsor selected ICON thanks in part to past positive partnership experiences, where we have successfully supported multiple new drug applications and post-approval activities for this organisation focused in rare disease areas. ICON’s CMC expertise helped overcome CMC-related challenges to ensure a timely approval for this new biologic drug. 

The Sponsor faced a complex regulatory environment in preparing a Canadian market application for a biologic product, with several critical obstacles that could have jeopardised approval timelines. Multiple third-party manufacturers and contract facilities were involved and Health Canada (HC) required facility-specific quality data not readily shared due to confidentiality concerns. Relying on master files instead would have increased the regulatory burden and risked delays. 

Additionally, one of the drug’s precursors had site compliance issues unique to Canada, potentially triggering a new inspection which would have been costly and time-consuming. Further complicating matters, the client expressed concerns about pre-approval inspection readiness and the logistics of sample provisioning during review, all of which could have negatively impacted the application's outcome.

ICON worked closely with the Sponsor, manufacturers and multidisciplinary internal teams to overcome each challenge while maintaining review timelines and ensuring regulatory compliance. ICON led proactive compliance reviews to determine the most essential quality documents, easing confidentiality concerns and guiding stakeholders to submit adequate, agency-compliant data. 

For the precursor site compliance issue, ICON’s experience with the Canadian review process helped identify a revised regulatory classification. We engaged directly with HC to mitigate risk without triggering inspection delays. Addressing the inspection readiness and sample provisioning concerns, ICON facilitated thorough documentation, streamlined stakeholder communication and satisfied all agency requirements to avoid additional inspection demands. Efficient management of the review process enabled smoother application and led to ultimate approval.  

ICON’s collaborative team approach leveraged specialist expertise and maximised internal efficiencies to deliver a positive outcome for the Sponsor. CMC experts and our Canadian Quality team ensured high quality data that met robust review standards while dedicated regulatory teams navigated a more efficient path through the Canadian review process while maintaining clear communication with all stakeholders. Ultimately, the optimised delivery approach and combination of global and local regulatory expertise resulted in the timely approval of the Sponsor’s new biologic drug.