OneSource Specialty Pharma, Formycon Partner to Manufacture Biosimilars for Global Markets

Under the agreement, OneSource will serve as Formycon's strategic manufacturing partner, providing integrated drug substance (DS) and drug product (DP) manufacturing services from its biologics manufacturing facility in Bengaluru.

The collaboration combines Formycon's expertise in biosimilar development with OneSource's end-to-end biologics manufacturing capabilities, with the aim of supporting Formycon's biosimilar programmes and expanding global access to affordable biologic therapies.

According to the companies, the partnership is designed to strengthen reliable, scalable and cost-effective manufacturing of biosimilars while supporting the growing global demand for high-quality biologic medicines.

Formycon has an established portfolio and pipeline of biosimilars, while OneSource offers an integrated biologics platform spanning cell line development, drug substance manufacturing, fill-finish operations and commercial production. The company also operates five manufacturing facilities approved by major global regulators, including the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA).

Commenting on the partnership, Neeraj Sharma, Managing Director and 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. It also reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacture of world-class biologics."

Dr. Stefan Glombitza, Chief Executive Officer of Formycon AG, said reliable, scalable and cost-efficient manufacturing remains a key pillar of the company's FYB4Growth strategy. He added that partnering with OneSource would strengthen Formycon's manufacturing network while maintaining high standards of quality, operational excellence and supply reliability for biosimilar products.

The companies said the partnership reflects their shared commitment to improving global access to biosimilars through sustainable manufacturing and operational excellence.