Collaboration begins with three monoclonal antibodies and establishes a pathway toward technology transfer and local production in Colombia for Latin America

MEDELLÍN, Colombia.

VaxThera S.A.S., a Colombian biotechnology company, and Hetero Biopharma Limited, an Hetero Group Company, a global pharmaceutical company with established expertise in biosimilars, announced a strategic alliance to expand timely and equitable access to high-cost biologic therapies in Colombia and Latin America.

As an initial step, the collaboration will focus on three monoclonal antibodies used in the treatment of oncology, autoimmune, and other complex diseases. This first portfolio marks the beginning of a broader long-term partnership aimed not only at improving access to essential therapies, but also at creating a pathway toward technology transfer, and future local manufacturing capabilities in Colombia.

By combining Hetero's extensive experience in the development and manufacturing of biosimilars with VaxThera's capabilities in biologics, advanced manufacturing, and regional market development, the two companies seek to establish a sustainable model that expands patient access to high-quality biologic therapies while progressively strengthening biopharmaceutical capabilities across the region.

For Latin America’s healthcare systems, this alliance comes at a particularly critical time. While biologic therapies have revolutionized how one treats cancer, autoimmune disorders and a host of other chronic ailments, getting patients to these medicines is still a matter of limited and protracted access. The figures from FIFARMA’s W.A.I.T. Indicator tell the story: in the region it takes 4.7 years on average for an innovative therapy to make its way from regulatory approval to the public system. In fact, just 35 per cent of what has been approved worldwide is available through those channels, a clear indication of the chasm between innovation and the patient.

There is also the matter of the region’s marginal role in the global biologics value chain to consider. Latin America may account for a good portion of the world’s population and its need for care, yet it contributes little to the manufacturing of biologics on a global scale. That leaves the area overly reliant on imports and foreign supply lines.

Overcoming such obstacles is not as simple as making a few more drugs available; it calls for building up regional capacity to ensure supplies are secure and affordable, and to speed up the path to advanced treatments down the line. It is with that end in view that the VaxThera-Hetero partnership was formed.

“This alliance represents an important step in VaxThera’s evolution as an integrated biotechnology company spanning prevention, biologic treatments, and personalized medicine. Beginning with three important monoclonal antibodies demonstrates our commitment to translating partnerships into concrete solutions for patients. Our objective is to expand access today while building the knowledge, technology, and manufacturing capabilities required to produce advanced biologics locally tomorrow,” said Professor Jorge Emilio Osorio, CEO of VaxThera.

Hetero Biopharma’s development and manufacturing of biosimilar medicines is supported by Hetero Labs Limited global corporate platform, which provides access to specialized research and development expertise, advanced manufacturing infrastructure, regulatory capabilities, and international commercial resources. Hetero Labs Limited operates more than 36 manufacturing facilities and maintains a direct commercial presence in more than 145 countries. Its biosimilar capabilities include nine global launches, with more than eight additional molecules currently under development and biosimilars available in over 45 countries. This integrated infrastructure is supported by comprehensive quality management systems and manufacturing processes aligned with international regulatory standards, including certifications and approvals from authorities.

The companies will work together to define the implementation roadmap, regulatory pathways, and future opportunities for localized capabilities. Additional information regarding specific programs and development milestones will be announced as they progress.

About HETERO:

Hetero is a global pharmaceutical company with integrated capabilities in research, development, manufacturing and commercialization of medicines, including biosimilars and other complex therapies. With an established international presence and more than 14 years of operations in Colombia, the company works to expand access to high-quality treatments through scientific expertise, advanced manufacturing infrastructure and robust regulatory capabilities. For more information, visit www.hetero.com.

About VaxThera:

VaxThera S.A.S. is a Colombian biotechnology company focused on advancing vaccines, biologics and advanced therapies through integrated research, development and manufacturing capabilities. The company works to strengthen health sovereignty, expand access to innovative health solutions and contribute to more resilient biopharmaceutical supply chains in Colombia and Latin America. For more information, visit www.vaxthera.com.

Press contact:

Federico Amaya

Cel. +57 304 618 0177

famaya@vaxthera.com