Formycon AG and OneSource Specialty Pharma Limited announced a strategic manufacturing partnership for biosimilars, aiming to strengthen supply capabilities and broaden global access to cost-effective biologic therapies. Under the agreement, OneSource will provide integrated Drug Substance and Drug Product manufacturing from its biologics facility in Bangalore, India, supporting Formycon’s biosimilar programs for worldwide markets.
The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities. Dr. Stefan Glombitza, CEO of Formycon, stated that reliable, scalable, and cost-efficient manufacturing is a cornerstone of the company’s 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,” he said.
Neeraj Sharma, Managing Director & CEO of OneSource, highlighted India’s role as a global hub for biologics manufacturing. “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,” he said.
The partnership is significant for the biosimilar industry, which is poised for substantial growth. According to the press release, global sales of biosimilars currently total around $21 billion, with projections to exceed $74 billion by 2030. This growth is driven by the patent expiration of many biopharmaceutical drugs—45 blockbusters with an estimated annual turnover of over $200 billion are set to lose patent protection by 2032. Biosimilars offer a pathway to reduce healthcare costs and increase patient access to life-changing therapies.
Formycon already has three biosimilars on the market—FYB201/ranibizumab, FYB202/ustekinumab, and FYB203/aflibercept—and four pipeline candidates, including FYB206/pembrolizumab and FYB208/dupilumab. The company’s FYB4Growth strategy focuses on geographic diversification, a smart portfolio strategy, excellence and innovation, and consistent cost efficiency. By partnering with OneSource, Formycon aims to enhance scalability and competitiveness through streamlined processes and optimized development structures.
OneSource operates five manufacturing facilities approved by leading global regulatory authorities, including the US FDA and EMA, and employs over 1,600 professionals. The company specializes in biologics, drug-device combinations, sterile injectables, and oral technologies. Its integrated platform spans cell line development through commercial fill-finish, positioning it as a key partner for Formycon’s global supply chain.
This partnership reflects a shared commitment to advancing biosimilar access through sustainable, high-quality manufacturing. For industry leaders, the collaboration underscores the importance of cost-efficient production in emerging markets, particularly India, to meet growing global demand for affordable biologics. The move could accelerate the adoption of biosimilars in regions with high unmet medical needs, potentially reshaping competitive dynamics in the pharmaceutical industry.
For more information about Formycon’s growth strategy, visit https://www.fyb4growth.com. Details about OneSource are available at www.onesourcecdmo.com.
