BioDlink Achieves Significant GMP Certification Milestone in Argentina for Global Expansion

BioDlink Strengthens Global Compliance with Argentina GMP Certification

The recent news of BioDlink receiving GMP certification from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) marks a significant milestone in the biopharmaceutical company’s global expansion strategy. This certification adds to an already impressive portfolio of international approvals for BioDlink, further cementing its position in the biotechnology market.

Founded in 2010, BioDlink has rapidly established itself as a powerhouse in biological drug production, currently boasting a substantial manufacturing capacity exceeding 20,000 liters. The Suzhou, China-based facility at the heart of this recent certification is where various biosimilar products are carefully produced, including the essential cancer treatment Pusintin® (bevacizumab) injection. This drug is critical in treating metastatic or recurrent non-squamous non-small cell lung cancer and metastatic colorectal cancer.

The GMP certification from Argentina emphasizes BioDlink’s commitment to delivering affordable and high-quality therapeutic alternatives, a necessity in today's healthcare landscape. Following its prior certifications in Brazil, Indonesia, Egypt, and Colombia, this new certification signifies an increasing acceptance of BioDlink's manufacturing methods and products in diverse international markets.

The rigorous inspection by ANMAT evaluated BioDlink’s adherence to stringent GMP standards, confirming that their operational practices align with global quality expectations. Dr. Jun Liu, CEO and Executive Director of BioDlink, highlighted the essential nature of this achievement, stating, "This GMP certification is a pivotal step in our global strategy and showcases our capabilities in providing reliable biosimilars on a large scale."

Partnering with Kexing Biopharm, a global licensee of Pusintin®, further positions BioDlink to better meet the demands of the Latin American market, which accounted for a significant 59.3% of the Latin American pharmaceutical market share in 2023. With Argentina emerging as a preferred destination for clinical trials, this development not only enhances BioDlink’s product availability but also impacts patient access to crucial oncology treatments in the region.

Dr. Kelvin Shao, Vice President of Kexing Biopharm, stressed the importance of these certification efforts, declaring that the partnership ensures consistent quality and broad availability of Pusintin®. He noted, "With our combined strengths, we are working towards increasing the accessibility of biosimilars, benefiting patients who rely on these crucial therapies."

The certification comes at a time when the global demand for monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates is rising. BioDlink’s production facility is strategically equipped with cutting-edge perfusion fed-batch technology and maintains a bioreactor capacity of 20,000 liters, accommodating an annual production capacity of 300,000 liters. This robust infrastructure is essential for addressing the growing biopharmaceutical needs across international markets.

As global healthcare initiatives evolve, BioDlink remains focused on its mission: "Empowering Innovation with Quality to Grow Together." This commitment not only drives their operational strategies but also reinforces dedication to enhancing healthcare worldwide.

In conclusion, BioDlink’s GMP certification in Argentina signifies a pivotal moment in its growth, ensuring that the company is well-positioned to lead the way in biopharmaceutical innovation and accessibility—for not only oncological therapies like Pusintin® but also across its entire range of biosimilars. With increasing recognition and compliance from multiple regulatory agencies, BioDlink is set to make a lasting impact on healthcare accessibility nationwide and globally.