Challenge: When clinical trials stop, waste doesn’t have to happen 

In March, the European Medicines Agency (EMA) released a pivotal Reflection Paper on biosimilar development. In response, a leading biosimilar manufacturer made the tough call to cancel its Phase III clinical trial for pembrolizumab. This left the sponsor with several thousand units of the drug – commercially packaged but decommissioned – sitting idle at a European packaging and labeling site. 

These units hadn’t gone through any GMP activities and, under normal circumstances, would have been destined for destruction. Reuse in another clinical trial was ruled out. The financial and environmental stakes were high. 

Solution: A creative, compliant path to reuse 

Rather than let this high-value, life-saving medication go to waste, BMclinical took decisive action. Our team explored every angle and identified a single, bold alternative: 

• Repatriation through parallel import: By leveraging the parallel import license of our sister company, we proposed repackaging and relabeling the unused pembrolizumab for use in Dutch hospitals. 

• Total supply chain transparency: We ensured product integrity with verified temperature logs and quality documentation. 

• Expert regulatory engagement: Our regulatory specialists drafted and submitted a detailed plan for repurposing the drug. Authorities in both the Netherlands and Germany approved it swiftly. 

Execution: Turning strategy into action 

We mobilized a high-performance, cross-functional team including experts in Quality, Clinical, Commercial and Finance, often 12+ people on calls, to coordinate every step. Collaboration between Uniphar | Global Sourcing, the client and the packaging partner ensured seamless documentation, traceability and compliance. 

The German Federal Ministry of Health supported our plan, reinforcing the legitimacy and alignment of our approach. 

Impact: A win for patients, the environment and our client 

• €6.5Million recovered: The client received a credit note, significantly softening the financial blow of the trial cancellation. 

• Patients treated: Rather than destroying life-saving oncology medication, we ensured it reached real patients in real hospitals. 

• Sustainability achieved: Avoided the unnecessary waste of valuable, complex pharmaceutical stock. 

• Stronger partnership: Our agile, mission-driven execution reinforced our value as a trusted strategic partner. 

How we can help you 

If you’re navigating clinical trial pivots, supply chain challenges, or sustainability goals – BMclinical can help you turn obstacles into opportunities. Whether through smart redeployment strategies, regulatory navigation or full-chain transparency, we deliver results that are ethical, impactful and commercially sound. 

Let’s talk about how we can do the same for you.