Introduction
Biologics are making an impact in the pharmaceutical industry, offering groundbreaking solutions for treating severe and chronic conditions. Closely following, biosimilars play the role of democratizing these treatments with their more accessible alternatives.
Derived from living organisms, biologics are large, complex molecules engineered to target specific components of serious and uncommon diseases. They have revolutionized treatments for conditions like cancer, autoimmune diseases, and rare genetic disorders, offering improved efficacy and fewer side effects compared to traditional drugs.
Biosimilars are highly similar versions of biologics, developed after the original biologic’s patent expires. They offer comparable safety, efficacy, and quality at a reduced cost, broadening patient access to life-saving therapies. Their cost has decreased due to the standardization of protein manufacturing and the rising accessibility of necessary technologies over the past ten years.
Together, biologics spearhead innovation, while biosimilars enhance healthcare accessibility. Their synergy is key to addressing both medical and economic challenges in global healthcare.
Challenges in Developing and Protecting Biologics
The development of biologics represents the best of pharmaceutical innovation but comes with significant challenges.
Biologics are highly complex and costly to produce, as they are derived from living cells and require advanced facilities, precise conditions, and extensive expertise. Developing a single biologic can take up to a decade and cost millions of dollars.
Intellectual property (IP) protection plays a crucial role in this process. Biologics are safeguarded by patents and exclusivity periods, which grant manufacturers temporary market control. This protection helps ensure that companies can recoup their significant investments in research and development (R&D). However, it can also limit competition and affect prices, impacting access.
That said, patent protections on biologics are time-limited. Recent reports show that fewer than 50% of biologics nearing patent expiry have a biosimilar candidate under development.
The combination of high production costs, regulatory complexities, and patent expirations highlights the need for solutions like biosimilars to provide more affordable options and reduce the financial burden on healthcare systems and patients.
Biosimilars: A Cost-Effective Solution
Biosimilars are transforming the pharmaceutical landscape by offering affordable alternatives to large-molecule biologics without compromising quality.
Still, they face regulatory challenges. Unlike small-molecule generics, biosimilars must undergo rigorous testing to demonstrate similarity in structure, function, and clinical outcomes to their reference biologics. This complex process includes analytical, preclinical, and clinical studies, making biosimilar development costly and time-intensive.
Companies producing biosimilars have different challenges than those producing small molecule generics, including higher failure rates and higher operating expenses.
However, they stand for increased accessibility. Once approved, biosimilars can reduce treatment costs by 15-35%. For example, biosimilars for oncology and autoimmune diseases have made critical therapies more accessible, especially in underserved markets. These cost savings allow healthcare systems to reallocate resources and improve patient outcomes globally.
By navigating regulatory hurdles and maintaining stringent quality standards, biosimilars hold the potential to democratize access to advanced medical treatments.
The Key Role of Biomanufacturing
Biomanufacturing is at the heart of producing biologics and biosimilars, ensuring consistent quality, safety, and scalability. It requires control of variables like temperature, pH, and nutrient levels to achieve consistency.
Manufacturing biologics demands precision and scale. Every step, from cell culture to purification, must meet exacting standards to ensure therapeutic efficacy and patient safety. The complexity of these processes drives up production costs, requiring cutting-edge technologies to optimize efficiency.
When producing biosimilars, manufacturers must replicate biologics’ properties while maintaining affordability to compete in the market. The process involves similar challenges but with an added emphasis on cost-effectiveness.
In any case, they both need innovations in process design and intensification [link], such as single-use technologies and advanced analytical tools, to streamline production and reduce costs.
Biomanufacturing involves producing using living organisms, a process inherently more unpredictable than chemical synthesis, the staple for generic small molecule production.
Adequate biomanufacturing is crucial for, enabling the delivery of safe, effective, and affordable therapies at scale. Additionally, local decentralized strategies could cut logistical costs, align production with regional healthcare needs, and meet patient demands in underserved regions.
Biomanufacturing with Stämm
Biologics and biosimilars, while distinct, share a common reliance on complex production techniques and facilities to meet patient and industry demands. At Stämm, we are reshaping biomanufacturing to address these challenges.
Stämm’s Bioprocessor, our continuous bioreactor, leverages process intensification to enhance efficiency, reduce resource consumption, and minimize environmental impact. This compact system is optimized to enable scalable and sustainable production of biologics or biosimilars at any scale. Thanks to its single-use cartridges, it enables a new level of flexibility to try out many drug candidates at the same time or re-scale production in the blink of an eye.
Our technologies cater to the demands of biologics and biosimilars, offering solutions that reduce costs while maintaining high-quality standards thanks to vascular systems that imitate the natural environment of cells and tissues. By mimicking nature, cells thrive on our bioreactors, maximizing quality and minimizing waste and stress due to a cleaner environment.
Our focus empowers manufacturers to expand treatment access to meet global demands by easily deploying our closed systems anywhere there is a controlled environment for production.
By streamlining processes, Stämm accelerates the production timeline and reduces operational costs, enabling faster delivery of therapies to patients, with the ability of producing locally thanks to the compact nature of our bioprocessors.
At Stämm, we believe the future of biomanufacturing lies in making it easy, scalable, repeatable, and sustainable. Together, we can transform how medicines are produced, ensuring that life-saving treatments reach more patients around the world.
