Formycon and OneSource Specialty Pharma Forge Strategic Manufacturing Partnership for Biosimilars

Formycon AG and OneSource Specialty Pharma have announced a strategic partnership to leverage OneSource's manufacturing capabilities for cost-efficient, scalable production of Formycon's biosimilar pipeline, aiming to expand global access to affordable biologics.

Miami Metrowire Staff
Business
Formycon and OneSource Specialty Pharma Forge Strategic Manufacturing Partnership for Biosimilars

Formycon AG (FSE: FYB) and OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) have entered into a strategic manufacturing partnership for biosimilars, combining Formycon's development expertise with OneSource's integrated drug substance and drug product manufacturing at its biologics facility in Bangalore, India. The collaboration is designed to support Formycon's biosimilar programs for global markets, reinforcing the company's FYB4Growth strategy centered on geographic diversification, smart portfolio management, excellence and innovation, and consistent cost efficiency.

Under the agreement, OneSource will serve as a strategic manufacturing partner, providing end-to-end biologics manufacturing capabilities from its state-of-the-art facility. Dr. Stefan Glombitza, CEO of Formycon AG, emphasized the importance of reliable, scalable, and cost-efficient manufacturing as a cornerstone of the FYB4Growth strategy. "By adding OneSource to our network of strategic manufacturing partners, we are further strengthening our supply capabilities with a partner that meets our unwavering commitment to high standards of quality, operational excellence and cost-efficiency," he said. "Together, we aim to broaden sustainable global access to life-changing biosimilar therapies."

Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, highlighted the partnership's role in expanding access to high-quality, affordable biologics. "This partnership brings together Formycon’s development expertise and OneSource’s integrated manufacturing capabilities to expand access to high-quality, affordable biologics for patients worldwide," he said. "It also reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacturing of world-class biologics."

Formycon already has three biosimilars on the market—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—with four pipeline candidates, including FYB206/pembrolizumab and FYB208/dupilumab, in development. OneSource brings an integrated biologics platform spanning cell line development through commercial fill-finish, five manufacturing facilities approved by leading global regulatory authorities including the US FDA and EMA, and extensive expertise across biologics, sterile injectables, and drug-device combinations.

The partnership reflects a shared commitment to advancing global access to biosimilars through sustainable, cost-effective manufacturing. With biosimilars creating competition and reducing costs for healthcare systems—global sales are expected to rise from around $21 billion to over $74 billion by 2030—the collaboration positions both companies to capitalize on the growing market as patents on blockbuster biologics expire. For more information about Formycon, visit https://www.formycon.com. For OneSource, visit www.onesourcecdmo.com.

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