OneSource Specialty Pharma, Formycon enter strategic manufacturing partnership for biosimilars

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The collaboration will see OneSource provide integrated biologics manufacturing services for Formycon’s global biosimilar pipeline from its Bengaluru facility, strengthening India’s role in global biologics manufacturing.

OneSource Specialty Pharma has entered into a strategic manufacturing partnership with Germany-based biosimilar developer Formycon AG to support the manufacture of biosimilar medicines for global markets.

Under the agreement, OneSource will provide integrated drug substance (DS) and drug product (DP) manufacturing services from its biologics manufacturing facility in Bengaluru. According to the companies, the collaboration is intended to combine Formycon’s biosimilar development capabilities with OneSource’s end-to-end biologics manufacturing platform.

The partnership aims to strengthen manufacturing capacity for Formycon’s biosimilar programmes while supporting the scalable production of biologic medicines for international markets.

Formycon has an established biosimilar portfolio, including marketed products referencing ranibizumab, ustekinumab and aflibercept, alongside a development pipeline that includes biosimilar candidates for pembrolizumab and dupilumab.

OneSource said its biologics platform spans cell line development through commercial fill-finish manufacturing and includes facilities approved by major international regulatory agencies. The company manufactures biologics, sterile injectables and drug-device combination products for global pharmaceutical companies.

Neeraj Sharma, Managing Director and Chief Executive Officer of OneSource Specialty Pharma, said the collaboration combines Formycon’s biosimilar development expertise with OneSource’s integrated manufacturing capabilities to improve global access to biologic medicines while reinforcing India’s role in biologics manufacturing.

Dr Stefan Glombitza, Chief Executive Officer of Formycon AG, said the agreement strengthens the company’s manufacturing network under its FYB4Growth strategy by adding a partner capable of supporting reliable, scalable and cost-efficient production.

The announcement reflects continued global collaboration between biosimilar developers and specialised contract development and manufacturing organisations (CDMOs) as companies seek diversified manufacturing capacity to support expanding biosimilar portfolios and international market access.