WARSAW, Poland and BUENOS AIRES, Argentina, 22 May 2026
Polpharma Biologics has entered a major licensing agreement with Tuteur to commercialize a biosimilar therapy for autoimmune diseases across Latin America, excluding Brazil. The partnership marks a significant strategic expansion for both companies in the rapidly growing biosimilars market and aims to improve patient access to high-quality, affordable biologic therapies throughout the LATAM region. Under the agreement, Polpharma Biologics will maintain responsibility for the development and manufacturing of the biosimilar candidate, while Tuteur will oversee commercialization, marketing, and regional distribution in the licensed territories.
Strategic LATAM Expansion for Biosimilars
The collaboration strengthens Polpharma Biologics’ international commercialization strategy while leveraging Tuteur’s strong regional infrastructure and expertise in specialty medicines. The biosimilar candidate, currently under development, is intended to provide an effective and well-tolerated treatment option for patients suffering from autoimmune disorders. Regulatory submissions are expected within the next three years, signaling a long-term growth opportunity for both organizations in the competitive immunology and biologics market.
Anjan Selz, CEO of Polpharma Biologics, stated that the agreement supports the company’s broader mission to expand global access to biosimilars. He emphasized that Tuteur’s deep commercial capabilities and established footprint across Latin America position the partnership to successfully deliver affordable biologic therapies to patients in need. Tuteur President Jonathan Hahn described the collaboration as a major milestone for the Argentina-based company, reinforcing its commitment to increasing access to advanced biologic medicines throughout the region.
Growing Demand for Affordable Autoimmune Therapies
The global demand for biosimilars targeting autoimmune diseases continues to rise as healthcare systems seek cost-effective alternatives to expensive branded biologic therapies. Latin America remains an important emerging market for biosimilars due to increasing chronic disease prevalence, healthcare access challenges, and rising pressure to reduce treatment costs. By combining Polpharma Biologics’ manufacturing and development expertise with Tuteur’s commercial reach, the companies aim to strengthen access to advanced therapies across multiple LATAM markets.
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Polpharma Biologics operates an integrated biosimilars platform headquartered in Switzerland and manages the full biosimilar value chain from product selection through commercialization. The company maintains a growing pipeline spanning early-stage development to marketed products and collaborates with global CDMO partners for manufacturing and supply capabilities. Tuteur, meanwhile, has built a strong reputation across Latin America in the distribution and commercialization of specialty medicines, with a focus on innovation, operational efficiency, and patient-centered healthcare solutions.
Biosimilar Market Continues Rapid Global Growth
The agreement reflects the continued momentum of the global biosimilars industry as pharmaceutical companies pursue regional partnerships to accelerate market penetration and improve affordability. Autoimmune diseases represent one of the largest and fastest-growing segments for biologic therapies, making biosimilars a key strategic focus area for companies seeking sustainable long-term growth. Industry analysts expect the LATAM biologics market to continue expanding over the next decade as regulatory pathways mature and healthcare systems increasingly adopt biosimilar alternatives.
With regulatory filing activities anticipated within three years, the partnership positions both companies to capitalize on growing demand for next-generation autoimmune biosimilars while supporting broader healthcare accessibility goals across Latin America.
Source: Polpharma Biologics press release
