OneSource Specialty Pharma Limited and Germany-based biosimilar developer Formycon AG have entered into a strategic manufacturing partnership to support the development and commercial supply of biosimilars for global markets.

Under the agreement, OneSource Specialty Pharma will serve as a strategic manufacturing partner for Formycon, providing integrated drug substance (DS) and drug product (DP) manufacturing capabilities from its biologics manufacturing facility in Bengaluru.

The collaboration brings together Formycon's expertise in biosimilar development with OneSource's end-to-end biologics manufacturing capabilities to support Formycon's expanding biosimilar portfolio and pipeline.

The companies said the partnership reflects their shared commitment to improving global access to high-quality, affordable biosimilars through reliable, scalable and cost-efficient manufacturing.

Formycon has built a strong track record in biosimilar development and commercialization, supported by an established product portfolio and a robust pipeline. 

OneSource complements this with an integrated biologics platform spanning cell line development to commercial fill-finish manufacturing. 

The company operates five manufacturing facilities approved by major global regulatory authorities, including the US Food and Drug Administration (FDA)and the European Medicines Agency (EMA), with expertise across biologics, sterile injectables and drug-device combination products.

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,” Sharma added.

Dr. Stefan Glombitza, Chief Executive Officer of Formycon AG, said manufacturing excellence is central to the company's long-term growth strategy. "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," he added.