Formycon AG, a leading independent developer of biosimilars, and OneSource Specialty Pharma Limited, a multi-modality specialty pharma CDMO, announced a strategic manufacturing partnership for biosimilars. Under the agreement, OneSource will provide integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its biologics facility in Bangalore, India, supporting Formycon's biosimilar programs for global markets.
The partnership aligns with Formycon's FYB4Growth strategy, which emphasizes reliable, scalable, and cost-efficient manufacturing. By adding OneSource to its network of strategic manufacturing partners, Formycon strengthens its supply capabilities to broaden sustainable global access to biosimilar therapies. Dr. Stefan Glombitza, CEO of Formycon AG, stated that the collaboration with OneSource meets the company's commitment to high standards of quality, operational excellence, and cost-efficiency.
Neeraj Sharma, Managing Director & CEO of OneSource Specialty Pharma, expressed delight in partnering with Formycon, a world-leading biosimilar developer. He noted that the partnership combines Formycon's development expertise with OneSource's integrated manufacturing capabilities to expand access to high-quality, affordable biologics for patients worldwide. Sharma also highlighted that India is uniquely positioned as a global hub for biologics development and manufacturing.
The partnership reflects both companies' shared commitment to advancing global access to biosimilars through reliable, high-quality, and scalable manufacturing. 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 global regulatory authorities including the US FDA and EMA, and extensive expertise across biologics, sterile injectables, and drug-device combinations.
Biosimilars are successor products to biopharmaceutical drugs whose patents have expired. They are approved under strict regulatory procedures in markets such as the EU, USA, Canada, Japan, and Australia. By creating competition, biosimilars broaden patient access to biopharmaceutical therapies and reduce healthcare system costs. Global biosimilar sales currently amount to around $21 billion, with analysts projecting a rise to over $74 billion by 2030.
Formycon's FYB4Growth strategy is built on four pillars: geographic diversification into high-growth regions like MENA, APAC, and Latin America; a smart portfolio strategy combining blockbuster molecules with niche products; excellence and innovation in technological and regulatory development; and consistent cost efficiency through streamlined processes and digital technologies. More details are available at FYB4Growth.
Formycon has three biosimilars on the market—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—and four pipeline candidates, including FYB206/pembrolizumab and FYB208/dupilumab. OneSource, a pure-play global CDMO, focuses on complex pharmaceutical products and has five state-of-the-art manufacturing facilities. For more information, visit Formycon and OneSource.
