Formycon And OneSource Specialty Pharma Announce Strategic Manufacturing Partnership For Biosimilars

Formycon AG and OneSource Specialty Pharma Limited, a multi-modality specialty pharma CDMO, today 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 Bangalore, 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 of 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.”

Neeraj Sharma, Managing Director & 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.”

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.

Formycon brings a strong track record in biosimilar development and commercialization, 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, five manufacturing facilities approved by leading global regulatory authorities, including the US FDA and EMA, and extensive expertise across biologics, sterile injectables, and drug-device combinations.

About Formycon:
Formycon AG is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich and listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. For more information, visit https://www.formycon.com/

About #FYB4Growth
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term. For more information, visit https://www.fyb4growth.com

About OneSource
OneSource Specialty Pharma Limited is a pure-play global CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five state-of-the-art manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,600 professionals. OneSource with its development capabilities, industry leading manufacturing capacities, and strong compliance track record, has won trust of global pharmaceutical companies seeking efficient, end-to-end solutions. For more information, visit www.onesourcecdmo.com.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.