Formycon and OneSource Specialty Pharma Forge Strategic Manufacturing Partnership for Biosimilars

Formycon AG and OneSource Specialty Pharma Limited have announced a strategic manufacturing partnership aimed at bolstering the production of biosimilars for global markets. Under the agreement, OneSource will provide integrated Drug Substance and Drug Product manufacturing from its biologics facility in Bangalore, India, supporting Formycon’s biosimilar pipeline.

The collaboration combines Formycon’s expertise in biosimilar development with OneSource’s end-to-end biologics manufacturing capabilities. Dr. Stefan Glombitza, CEO of Formycon, emphasized that reliable, scalable, and cost-efficient manufacturing is central to the company’s FYB4Growth strategy. By adding OneSource to its network of strategic partners, Formycon aims to strengthen supply capabilities while maintaining high standards of quality and operational excellence.

Neeraj Sharma, Managing Director & CEO of OneSource, highlighted that the partnership reinforces India’s position as a global hub for biologics development and manufacturing. “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.

The partnership reflects a shared commitment to advancing global access to biosimilars through sustainable, cost-effective manufacturing. Formycon brings a strong track record with three marketed biosimilars—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—and a pipeline including FYB206/pembrolizumab and FYB208/dupilumab. OneSource operates five manufacturing facilities approved by the US FDA and EMA, offering expertise across biologics, sterile injectables, and drug-device combinations.

Biosimilars are increasingly important as many biopharmaceutical drugs lose patent protection. By 2032, an estimated 45 blockbuster biologics with combined annual sales exceeding $200 billion will face biosimilar competition. Global biosimilar sales currently stand at about $21 billion and could rise to over $74 billion by 2030, according to analysts. This partnership positions both companies to capture a share of this growing market.

Formycon, headquartered in Munich and listed on the Frankfurt Stock Exchange, focuses on developing high-quality biosimilars from candidate selection through to market delivery. OneSource, a pure-play CDMO listed on Indian stock exchanges, brings development capabilities and a team of over 1,600 professionals. The partnership is expected to enhance the scalability of Formycon’s business model and strengthen its competitiveness in the long term.

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