Regulatory Filing Details
Partnership Details
OneSource Specialty Pharma Limited (Indian multi-modality specialty pharma CDMO) and Formycon AG (German independent biosimilar developer, FSE: FYB) have entered into a strategic manufacturing partnership for biosimilars.
Under the partnership:
- OneSource will serve as strategic manufacturing partner for Formycon
- OneSource will provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing capabilities
- Manufacturing will be conducted from OneSource's state-of-the-art biologics facility in Bangalore
- The collaboration combines Formycon's biosimilar development excellence with OneSource's end-to-end biologics manufacturing expertise
- The partnership supports Formycon's biosimilar programs for global markets
Strategic Rationale
The partnership reflects both companies' commitment to advancing global access to biosimilars through reliable, high-quality, and scalable manufacturing. The collaboration aims to achieve a sustainable, cost-effective manufacturing model that OneSource is positioned to deliver.
Company Capabilities Highlighted
Formycon's Contributions:
- Strong track record in biosimilar development and commercialization
- Established portfolio and robust pipeline
- Three biosimilars already on market: FYB201/ranibizumab, FYB202/ustekinumab, FYB203/aflibercept
- Four pipeline candidates in development: including FYB206/pembrolizumab and FYB208/dupilumab
- Covers entire value chain from candidate selection to market-ready product
OneSource's Contributions:
- Integrated biologics platform spanning cell line development through commercial fill-finish
- Five manufacturing facilities approved by leading global regulatory authorities including US FDA and EMA
- Expertise across biologics, sterile injectables, and drug-device combinations
- Over 1,600 professionals
Executive Commentary
Neeraj Sharma, Managing Director & CEO, OneSource Specialty Pharma: Expressed delight in partnering with Formycon, noting it reinforces India's position as a global hub for biologics development and manufacture.
Dr. Stefan Glombitza, Chief Executive Officer of Formycon AG: Stated that reliable, scalable and cost-efficient manufacturing is a cornerstone of their FYB4Growth strategy, and OneSource meets their commitment to high standards of quality, operational excellence and cost-efficiency.
About the Companies
OneSource Specialty Pharma Limited: Pure-play global CDMO focusing on development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules).
Formycon AG: Leading independent developer of high-quality biosimilars, covering entire value chain from selection through development to delivery of approved products. Headquartered in Munich, listed in Prime Standard of Frankfurt Stock Exchange (FYB/ISIN: DE000A1EWVY8/WKN: A1EWVY).
FYB4Growth Strategy Context
The partnership aligns with Formycon's FYB4Growth strategy based on four pillars: geographic diversification, smart portfolio strategy, excellence and innovation, and consistent cost efficiency.