Formycon and OneSource Specialty Pharma have announced a strategic manufacturing partnership for biosimilars.

Under the partnership, OneSource will serve as a strategic manufacturing partner for Formycon and provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing capabilities from its state of the art biologics’ facility in Bengaluru, India. The collaboration brings together Formycon’s biosimilar development excellence with OneSource’s end-to-end biologics manufacturing expertise to support Formycon’s biosimilar programs for global markets.

Dr. Stefan Glombitza, Chief Executive Officer (CEO), Formycon AG, said, “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. Together, we aim to broaden sustainable global access to life-changing biosimilar therapies.”

The partnership reflects the shared commitment of both companies to advancing global access to biosimilars through reliable, high-quality, and scalable manufacturing. Achieving this requires not only scientific excellence but also a sustainable, cost-effective manufacturing model–one that OneSource is specifically positioned to deliver.

Neeraj Sharma, Managing Director and CEO, 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. 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 brings a strong track record in biosimilar development and commercialisation, supported by an established portfolio and a robust pipeline. OneSource complements this with an integrated biologics platform spanning cell line development through commercial fill-finish, 5 manufacturing facilities approved by global regulatory authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and extensive expertise across biologics, sterile injectables, and drug-device combinations.