Formycon AG and OneSource Specialty Pharma Limited announced a strategic manufacturing partnership for biosimilars, combining Formycon's development expertise with OneSource's integrated drug substance and drug product manufacturing capabilities from its biologics facility in Bangalore, India.
Under the partnership, OneSource will serve as a strategic manufacturing partner for Formycon, providing end-to-end biologics manufacturing to support Formycon's biosimilar programs for global markets. The collaboration aims to broaden sustainable global access to life-changing biosimilar therapies by ensuring reliable, scalable, and cost-efficient manufacturing.
Dr. Stefan Glombitza, CEO of Formycon AG, stated: "Reliable, scalable and cost-efficient manufacturing is a cornerstone of our 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."
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, said: "We are delighted to partner with Formycon, one of the world’s leading biosimilar developers with a proven track record of bringing high-quality biosimilars to global markets. 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."
The partnership reflects a shared commitment to advancing global access to biosimilars through sustainable, cost-effective manufacturing. OneSource's facility is approved by leading global regulatory authorities, including the US FDA and EMA, and offers expertise across biologics, sterile injectables, and drug-device combinations. Formycon brings a strong track record with three biosimilars on the market—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—and four pipeline candidates, including FYB206/pembrolizumab and FYB208/dupilumab.
Formycon's FYB4Growth strategy includes geographic diversification into high-growth regions, a smart portfolio strategy combining blockbuster molecules with niche products, technological and regulatory innovation, and consistent cost efficiency. OneSource's integrated biologics platform spans cell line development through commercial fill-finish, with five manufacturing facilities and over 1,600 professionals.
The biosimilar market is poised for significant growth, with global sales expected to rise from around $21 billion to over $74 billion by 2030, as patents for many biopharmaceuticals expire. This partnership positions both companies to capture a share of that growth while improving patient access to affordable biologics.
For more information about Formycon and its FYB4Growth strategy, visit https://www.formycon.com/ and https://www.fyb4growth.com. Details about OneSource can be found at www.onesourcecdmo.com.
