Executive Summary
A pharmaceutical company enquired us for Ultomiris®, a highly regulated specialty biologic distributed under a REMS (Risk Evaluation and Mitigation Strategy) program with ETASU (Elements to Assure Safe Use) requirements. Accessing this drug required covered product authorization (CPA) requirements by the FDA.
Spring Bio Solution successfully sourced the product and supported the covered product authorization process, enabling compliant access to this hard-to-source therapy through a streamlined process.
The Challenge
Ultomiris is a specialty biologic used to treat rare diseases like Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), and Neuromyelitis Optica Spectrum Disorder (NMOSD). Due to its REMS + ETASU status, procurement involves comparatively more complexity than conventional pharmaceutical sourcing.
Organizations requiring Ultomiris need to tackle challenges like
- Restricted distribution channels
- REMS program requirements
- Covered Product Authorization (CPA) processes
- Regulatory and documentation requirements
- Limited market availability through conventional procurement routes
- Restricted purchasing eligibility
Many comparator sourcing companies face the challenge of understanding the access pathways and compliance requirements necessary to obtain the product legally and efficiently. Due to a lack of specialized expertise and established relationships, sourcing efforts can face significant delays and uncertainty.
Spring Bio Solution’s Approach
Leveraging more than 15 years of experience in comparator sourcing, RLD procurement, and specialty pharmaceutical access, Spring Bio Solution activated its global sourcing and compliance network to make this drug available to the pharmaceutical company in need.
Our team aced the sourcing task with the following action items:
- Identified a compliant sourcing pathway for Ultomiris
- Coordinated access through authorized supply channels
- Supported the Covered Product Authorization process
- Assisted with documentation and compliance requirements
- Managed communication across stakeholders to streamline execution
We delivered end-to-end support to help the client successfully access a highly restricted product category. We are grateful for our client’s satisfactory response after receiving the delivery.
Outcome & Impact
- Successful sourcing of Ultomiris through compliant channels, ensuring trial readiness without regulatory delays
- Regulatory requirements and documentation are managed efficiently, reducing compliance risk for the sponsor
- Reduced complexity in sourcing and shortened procurement timelines, accelerating study initiation
- Single-point coordination for product access and compliance support, simplifying vendor management and improving operational efficiency
Key Capabilities Demonstrated
- Expertise in REMS + ETASU product sourcing
- Support for Covered Product Authorization processes
- 15+ years of specialty pharmaceutical sourcing experience
- 400+ global distribution partners
- 75+ manufacturer relationships worldwide
Facing a Comparator or Specialty Drug Sourcing Challenge?
If you are sourcing REMS + ETASU products, biologics, orphan drugs, radiopharmaceuticals, hospital-specific products, retail-exclusive therapies, enteral feeding devices, or specialized pharmaceutical materials, Spring Bio Solution can be your best choice for identifying compliant sourcing pathways and providing these drugs in a timely manner with assured compliance.