Formycon AG (FSE: FYB) and OneSource Specialty Pharma Limited (BSE: 544292, NSE: ONESOURCE) have announced a strategic manufacturing partnership focused on biosimilars. Under the agreement, OneSource will provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing services from its biologics facility in Bangalore, India, supporting Formycon’s biosimilar programs for global markets.
The partnership aligns with Formycon’s FYB4Growth strategy, which emphasizes reliable, scalable, and cost-efficient manufacturing. Dr. Stefan Glombitza, CEO of Formycon AG, stated: “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. Together, we aim to broaden sustainable global access to life-changing biosimilar therapies.”
OneSource brings end-to-end biologics manufacturing expertise, including cell line development through commercial fill-finish, and operates five facilities approved by global regulatory authorities such as the US FDA and EMA. Neeraj Sharma, Managing Director & CEO of OneSource, commented: “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. 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, a leading independent biosimilar developer, already has three biosimilars on the market—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—and four pipeline candidates, including FYB206/pembrolizumab and FYB208/dupilumab. The company’s FYB4Growth strategy focuses on geographic diversification, smart portfolio selection, excellence and innovation, and consistent cost efficiency. More details on this strategy can be found at https://www.fyb4growth.com.
The collaboration addresses the growing demand for biosimilars as patents for major biopharmaceuticals expire. By 2032, blockbuster biologics with combined annual sales exceeding $200 billion are expected to lose patent protection. Biosimilars, which currently generate global sales of around $21 billion, are projected to reach over $74 billion by 2030, creating competition that lowers healthcare costs and expands patient access.
OneSource, a pure-play global CDMO, specializes in biologics, drug-device combinations, sterile injectables, and oral technologies. Its manufacturing facilities and team of over 1,600 professionals provide end-to-end solutions for pharmaceutical companies. Additional information about OneSource is available at https://www.onesourcecdmo.com.
This partnership underscores the shared commitment of both companies to advancing global access to biosimilars through sustainable, high-quality manufacturing. By combining Formycon’s development prowess with OneSource’s manufacturing capabilities, the alliance aims to deliver affordable biologic therapies to patients worldwide.
