Driving the Shift to Subcutaneous Biologics

The subcutaneous shift has already happened.

Is your pipeline ready?

In 2000–2004, 25% of FDA biologic approvals were device-based. By 2023-2025, 74% were. OneSource delivers the complete subcutaneous (SC) development stack – DNA to device – under one quality system, one site, one regulatory dossier.

Whitepaper Abstract:

Achieving SC delivery of a high-dose biologic requires overcoming four challenges simultaneously: concentrating a protein to 100-250 mg/mL, controlling viscosity so it remains syringeable, absorbing it reliably through subcutaneous tissue, and delivering it in a device patients can self-administer. Most CDMOs solve one or two; very few provide the end-to-end stack innovators, biotechs, and biosimilar developers actually need.

OneSource Specialty Pharma, India’s first specialty pharma pure play CDMO, is built to close that gap. The HILOPRO® formulation platform, patented by Bhami Research Lab and accessed by OneSource through strategic partnership, validated across six commercial molecules, solves the central concentration, viscosity trap. An integrated DS+DP campus in Bengaluru, full device assembly capability, and a regulatory track record of 200+ inspections cleared along with 40+ commercialized US products provide the operational backbone. A teriparatide programs already approved in the European Union proves the integrated DNA to Device pathway in practice for biologics.

This paper is organized in three sections:

• the SC shift and the four challenges programs must solve
• the industry toolkit and the OneSource solution stack;
• engagement models for innovators and biosimilar developers, and why the window to act is open but narrowing.