Bangalore-based OneSource Specialty Pharma Ltd and Sweden-headquartered Xbrane Biopharma AB have announced a high-impact partnership focused on the commercial-scale manufacturing of biosimilars, aiming to serve the global pharmaceutical markets. This collaboration aligns two industry specialists — OneSource as a biologics CDMO (Contract Development and Manufacturing Organization) and Xbrane as an innovator in biosimilar R&D — to create an integrated, globally compliant biologics supply platform.

Overview of the Partnership

The cornerstone of this collaboration is the tech transfer of select biosimilar assets from Xbrane to OneSource’s state-of-the-art DS/DP (Drug Substance/Drug Product) facility in Bangalore, India. This enables Xbrane to achieve cost-effective, quality-controlled, and scalable manufacturing to meet growing global demand for biosimilars.

OneSource, on the other hand, leverages this partnership to accelerate regulatory readiness of its Bangalore biologics unit — especially with regard to approvals from:

• U.S. FDA (Food and Drug Administration)

• EMA (European Medicines Agency)

This dual approach reinforces the long-term commercial alignment between the companies, further solidified by OneSource’s participation in Xbrane’s recent funding round.

Xbrane’s Pipeline and Market Potential

Xbrane Biopharma has built a robust pipeline of biosimilars that collectively target a market opportunity of over EUR 23 billion in annual peak sales. Its lead asset, Ximluci (a ranibizumab biosimilar), already has market authorization in Europe and is in the process of seeking U.S. FDA approval.

Ranibizumab, the reference product for Ximluci, is widely used in ophthalmology for treating age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). With biosimilar versions like Ximluci entering the market, treatment accessibility and affordability are expected to rise globally.

Key Highlights of the Manufacturing Alliance

1. Commercial Manufacturing at Bangalore Facility
   The core deliverable is the commercial-scale production of biosimilars at OneSource’s Bangalore unit. The site is equipped with integrated biologics capabilities, covering both drug substance and drug product manufacturing.

2. Technology Transfer
   Xbrane will transfer technology for its biosimilars, beginning with Ximluci, to OneSource. This not only enables efficient global distribution but also builds strategic manufacturing redundancy, reducing dependence on a single geography.

3. Global Regulatory Synergy
   OneSource’s facility is being prepared for regulatory inspections and certifications from leading global health authorities. This will position OneSource as a qualified manufacturing partner for EU and US market supply.

4. Long-Term Investment and Strategic Alignment
   As part of the agreement, OneSource also invested in Xbrane’s recent funding round, ensuring deeper business collaboration and aligned financial interest for future growth.

Leadership Commentary

Neeraj Sharma, MD & CEO of OneSource Specialty Pharma, emphasized that the collaboration supports affordable access to advanced biologics, further advancing the company's mission of being a trusted global CDMO partner.

“Xbrane’s success in biosimilars, combined with OneSource’s biologics platform, sets the stage for significant global impact in the accessibility of biologics,” he noted.

Martin Åmark, CEO of Xbrane Biopharma, acknowledged the value of this partnership in meeting cost and compliance expectations globally, stating:

“OneSource offers us competitive manufacturing with strong regulatory experience, helping us expand our market reach while lowering therapy costs for patients.”

Global Biosimilars: Market Context

The global biosimilars market is growing at an exponential pace, driven by:

• Expiry of major biologics patents

• Cost pressures on healthcare systems

• Increasing acceptance of biosimilars by physicians and payers

• Regulatory streamlining in US, Europe, and emerging markets

By partnering with OneSource, Xbrane can:

• Ensure price-competitive production

• Access a reliable CDMO with end-to-end biologics expertise

• Tap into India’s skilled workforce and cost efficiencies

India as a Biosimilars Manufacturing Hub

India has rapidly emerged as a critical node in the global biosimilar supply chain, thanks to:

• FDA and EMA-compliant facilities

• Low manufacturing cost base

• Highly skilled biotechnology talent

• Government incentives and regulatory support for biopharma investments

OneSource’s Bangalore facility is a testament to India’s maturing biologics infrastructure. The site is fully equipped to handle:

• Upstream & downstream biologics production

• Aseptic fill-finish

• Stability studies and regulatory documentation

• Cold chain logistics for biologics

Impact on Biopharma Ecosystem

This partnership reflects the future model of global biopharma partnerships, where:

• Innovation remains centralized in R&D-focused hubs like Europe or the U.S.

• Cost-effective and quality manufacturing is carried out in regions like India

• Shared investment and mutual strategic alignment enable sustainable market penetration

Why This Matters: Key Implications

• Patients: Faster access to affordable life-saving biologics

• Healthcare Providers: Greater confidence in supply chain and pricing stability

• Regulators: Compliance assurance through joint accountability between partners

• Biopharma Industry: Model for collaborative innovation and shared risk in scaling production

Conclusion: Creating a Global Biosimilars Supply Chain

The collaboration between OneSource Specialty Pharma and Xbrane Biopharma is more than just a business deal — it is a blueprint for global biosimilar commercialization, combining European innovation and Indian manufacturing strength.

As the industry evolves toward integrated, efficient, and quality-centric biologics manufacturing, partnerships like these will define how biologics reach patients faster and more affordably across the world.

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