Biologic drugs have revolutionized healthcare for various hard-to-treat conditions, yet access remains restricted, especially in emerging markets, largely owing to the high cost of these drugs. For over four decades, Biosidus has led in the development and manufacture of biosimilars, driving broader global access through innovative production techniques and strategic global distribution. Committed to quality and sustainability, the company’s operations incorporate local production facilities worldwide to meet diverse medical needs efficiently and sustainably, ensuring a reliable supply of high-quality biosimilars.
Enhancing Global Health through Expanded Biosimilar Access
Biologic drugs have revolutionized treatment for numerous diseases where traditional small molecule medicines fall short. Despite their effectiveness, access to these expensive medications remains limited; approximately 85% of biopharmaceuticals are consumed by patients in just seven mature economies. Biosimilars — officially approved, lower-cost versions of these biologics after original patents expire — offer a promising solution. Typically priced 15% to 30% lower than their branded counterparts, biosimilars could dramatically broaden global access to life-changing treatments.
Biosimilars are crucial in transforming the global healthcare landscape, providing more affordable alternatives to costly biologic drugs. Their adoption can significantly cut healthcare costs, allowing systems to redistribute savings to broaden and enhance services, thus reaching more patients with essential treatments.
However, ensuring a steady, reliable supply of high-quality biosimilars, particularly to emerging markets, remains a formidable challenge. Like their originator biologic counterparts, biosimilars require complex development and manufacturing processes. It is critical that manufacturers demonstrate their biosimilars match the reference products in purity, safety, and effectiveness through comprehensive analysis.
As such, biosimilars must meet rigorous standards set by national or regional regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Importantly, emerging markets are beginning to adopt similar regulatory frameworks, which support local manufacturers in navigating the approval process more efficiently and foster a competitive marketplace that benefits healthcare systems and patients alike. As regulatory frameworks continue to evolve and manufacturers expand their expertise, the influence of biosimilars is set to increase, promising significant public health benefits worldwide.
Strengthening Global Access through Biosidus’s Biosimilar Production
Biosidus, an innovator in biotechnology based in Argentina, has been at the forefront of developing and manufacturing biosimilars for over four decades. With a strong foundation in research and development, Biosidus is committed to providing affordable and high-quality biotherapeutics to patients globally, particularly in underserved markets.
The production of biosimilars at Biosidus is centralized in three specialized facilities within Buenos Aires, Argentina. The Almagro plant, nestled in the heart of the city, is dedicated to the production of drug substances using mammalian cell culture and bacterial fermentation, including nine distinct biosimilars. These substances are then processed under sterile conditions at the Bernal plant, situated in the southern region of the city. Here, the biosimilars are formulated into their final forms, either as liquid or freeze-dried products, to enhance stability, and subsequently filled into vials or syringes.
Additionally, a third facility, also located in southern Buenos Aires, serves as a strategic warehouse from which Biosidus distributes its products both domestically and to over 50 countries globally.
Throughout its production cycle, Biosidus employs cutting-edge analytical technologies to ensure product quality. These include a variety of chemical, physical, and biological assays, both in vitro and in vivo, essential for in-process control and final product quality assurance.
Maintaining Excellence in Regulatory Compliance
Over the last three decades, Biosidus has consistently demonstrated its commitment to regulatory excellence, undergoing rigorous audits by various international regulatory agencies. Biosidus has been successfully audited by various prominent regulatory bodies, such as ANVISA in Brazil, COFEPRIS in Mexico, and INVIMA in Colombia.
This strategic focus on emerging markets is reflected in the company's marketing authorizations, which are exclusively in these regions. This approach not only aligns with Biosidus's mission to enhance access to biosimilars where they are most needed but also allows the company to tailor its compliance strategies to the specific regulatory environments of these markets.
This impeccable compliance record reassures global partners and patients of its reliability as a leading biosimilar manufacturer, particularly in emerging markets where access to affordable biologic treatments is crucial.
Expanding Global Reach through Strategic Distribution
Biosidus has established a robust global distribution network to ensure the reliable delivery of its biosimilar products to customers worldwide, regardless of their geographical location. The network includes commercial subsidiaries and distribution affiliates strategically located across Central and South America, the Middle East, Africa, and beyond. This setup is designed to guarantee security of supply and effective market penetration.
Continuously, Biosidus is committed to expanding the volume of products shipped to existing markets and exploring new markets that stand to benefit from its high-quality, cost-effective biosimilars. These efforts are critical in extending the reach of affordable biologic treatments globally, supporting Biosidus's mission to enhance patient access to essential therapies.
Robust Supply Chain for Biosimilar Manufacturing
Biosidus maintains an extensive list of qualified suppliers to ensure a steady delivery of high-quality raw materials and consumables essential for biosimilar production. The company has adopted a strategic sourcing approach, which includes rigorous review and qualification of suppliers, as well as maintaining redundant supplies of critical components to avoid any disruptions in production.
Furthermore, Biosidus's manufacturing processes for biosimilars are exceptionally robust, employing a quality-by-design approach. This strategic method ensures that the processes are adaptable and can effectively utilize raw materials from various suppliers without compromising the quality and efficacy of the final biosimilars.
This comprehensive and proactive supply chain strategy not only secures the necessary inputs for continuous production but also supports Biosidus’s commitment to providing reliable and effective biosimilar therapies globally.
Promoting Biosimilar Acceptance through Education
Biosidus recognizes that broadening access to biosimilars in emerging markets begins with comprehensive education. Both physicians and patients need to understand the safety and benefits associated with biosimilar use. To address this, Biosidus designs its biosimilars with the end-user in mind, ensuring ease of use across various market conditions. This includes considerations for product design, delivery mechanisms, and culturally appropriate packaging and labeling.
Additionally, Biosidus adopts a patient-centric approach in its global operations, exemplified by its multiple distribution sites worldwide. These sites not only facilitate local support but also reflect the company's commitment to making innovative medical treatments universally accessible — not just privileges for the affluent. Through this strategy, Biosidus actively contributes to creating a more equitable healthcare landscape, ensuring that essential medical treatments are within reach of those who need them most.
Innovative Practices for Sustainable Biosimilar Production
While biosimilars function analogously to generics in the realm of small molecule drugs, innovation remains crucial for gaining a competitive edge in a market teeming with new entrants. Committed to enhancing access to novel biologic medicines, Biosidus invests in cutting-edge manufacturing techniques.
A standout project at Biosidus involves the use of transgenic animals (cows), a pioneering alternative to traditional cell culture and fermentation processes in large bioreactors. Although transgenic plants are already used for biologics production, transgenic animals represent a novel frontier in biomanufacturing. This approach offers several advantages: significantly smaller production footprints, drastic reductions in single-use plastic consumption, lower water usage, and decreased wastewater production. Additionally, the risk of contamination is potentially reduced due to minimal exposure during manufacturing, presenting a cleaner, more efficient method of production.
Strategic Expansion and Unwavering Commitment to Quality at Biosidus
Biosidus is dedicated to its mission of growth while ensuring the reliable supply of high-quality biosimilars to an expanding patient base worldwide. The company's operational philosophy is rooted in meeting increasing demand with products that adhere to the highest standards of quality. This commitment is embedded across all facets of operations, from quality control and assurance to an ingrained quality culture that permeates the entire organization, from senior management to every employee.
This quality-centric approach underpins both manufacturing and expansion efforts. Biosidus is actively extending its market reach into Latin America, Africa, Asia, and Europe, thereby solidifying its robust international presence. Key to its strategy is the establishment of local production facilities to mitigate logistical costs and navigate import restrictions effectively. For instance, a new facility in Algeria is set to enhance Biosidus's capabilities, starting with packaging and evolving to full production, tailored specifically to meet the needs of the local population and guarantee a consistent supply chain.
Strategic partnerships remain a cornerstone of Biosidus's growth strategy, facilitating entry into new markets and expansion of its biosimilar and small molecule generic portfolios, particularly in regions where demand is surging, such as Asia, Africa, and the Middle East, as well as in well-established markets like Europe and North America. These alliances are crucial for improving market access and easing regulatory pathways.
Moreover, Biosidus is advancing a promising pipeline of new biosimilars aimed at treating rare diseases like lysosomal storage disorders, some of the most expensive conditions to manage. By introducing biosimilars for these conditions, Biosidus strives to make treatments more accessible and affordable, improving patient outcomes. The company is also exploring innovative biopharmaceuticals that utilize cutting-edge technologies for enhanced therapeutic effects.
Through these multifaceted strategies, Biosidus not only aims to broaden its global footprint but also to fulfill its role in addressing global health challenges by increasing access to essential medicines in emerging and underserved markets.
