Chime Biologics, a leading global Contract Development and Manufacturing Organization (CDMO), has announced a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and manufacture of biosimilar products for global markets. The partnership, announced on April 16, 2025, will span from investigational new drug (IND) applications to commercial supply, highlighting both companies' commitment to expanding access to affordable biological medicines.
Under the terms of the agreement, Chime Biologics will leverage its comprehensive development and manufacturing capabilities to support Polpharma Biologics' biosimilar program, including production for US FDA Biologics License Application (BLA) submissions and expansion into European Union and other global markets.
Strategic Significance for Both Companies
Polpharma Biologics, the largest biotechnology company in Poland and a significant player in the global biosimilar market, brings to the partnership a robust pipeline that includes multiple early and late-stage biosimilars. The company already has two FDA/EMA-approved biosimilar products in its portfolio, positioning it as an established developer in this rapidly growing sector.
Dr. Jimmy Wei, President of Chime Biologics, emphasized the strategic importance of the collaboration: "We are thrilled to contribute to Polpharma Biologics' growth as we provide all-in-one solutions to accelerate biosimilar development and reduce the time-to-market. This collaboration reinforces our strategy of delivering high-quality, affordable biologics to patients worldwide."
The partnership represents a significant step in Chime Biologics' expansion into the European market while strengthening Polpharma Biologics' manufacturing capabilities and global reach.
Comprehensive Development and Manufacturing Support
Chime Biologics will provide a complete suite of services through its end-to-end platform, including state-of-the-art cell line development, process optimization, analytical development, and manufacturing capabilities. This comprehensive approach is designed to streamline the development process and accelerate market entry for biosimilar products.
The CDMO's track record in delivering biosimilars for global markets positions it well to meet the growing worldwide demand for these more affordable alternatives to original biological medicines. Chime's integrated approach to Chemistry, Manufacturing, and Controls (CMC) development and commercial supply is expected to significantly reduce development timelines.
Meeting Global Patient Needs
Konstantin Matentzoglu, Member of the Supervisory Board of Polpharma Biologics Group BV, highlighted the patient-centered focus of the partnership: "Partnering with Chime Biologics supports our strategic vision to swiftly bring affordable biosimilars developed in Europe to global markets. By working with Chime Biologics, we can accelerate patient access to biosimilar therapies."
Matentzoglu added that the partnership "further strengthens Polpharma Biologics' global position as a leading biosimilars developer, while leveraging Asian partners with optimized cost-benefit ratio."
Biosimilars Market Growth
The collaboration comes at a time when the global biosimilars market is experiencing significant growth. Biosimilars offer cost-effective alternatives to original biological medicines, which are often among the most expensive treatments available. By increasing competition in the biologics space, biosimilars help reduce healthcare costs while expanding patient access to critical therapies.
The partnership between Chime Biologics and Polpharma Biologics represents a strategic alignment of complementary capabilities aimed at addressing the technical and regulatory challenges of biosimilar development while accelerating the delivery of these important medicines to patients worldwide.
About the Companies
Polpharma Biologics operates as an international biotechnology company with integrated operations in the European Union. The company develops biosimilar therapies across major therapeutic areas, with capabilities spanning from cell line development through technical and clinical development to commercial-scale production. Its approved biosimilars include ranibizumab and natalizumab, with development and manufacturing centers in Poland and a cell line development center in The Netherlands.
Chime Biologics positions itself as a comprehensive biologics service provider, offering support from pre-clinical development through to commercial manufacturing of drug substances and drug products. The company employs innovative development and manufacturing capabilities to support clients with clinical and commercial authorizations globally, with a stated mission of making cutting-edge biomedicines affordable and accessible to patients worldwide.
