Interferon and erythropoietin therapies are essential for treating a range of conditions including viral infections, kidney diseases, neurological disorders, and cancer. Despite their effectiveness, the high costs associated with these treatments restrict access for many potential patients globally. Biosidus is addressing this challenge by offering high-quality, cost-effective biosimilar versions of these drugs. Through its commitment to bridging the gap between innovative scientific research and practical healthcare solutions, Biosidus is enhancing global access to essential medical treatments.
High Therapeutic Value for Interferon and Erythropoietin
Interferons and erythropoietin are essential proteins naturally produced by the human body, each playing a crucial role in maintaining health. Interferons are pivotal in the immune response, while erythropoietin primarily stimulates the production of red blood cells. Insufficient levels of these proteins can lead to significant health complications.
There are three types of interferons produced by biotechnology: interferon alfa (IFN-a), interferon beta (IFN-b), and interferon gamma (IFN-g). These cell-signaling cytokines are used to treat a range of diseases, including multiple sclerosis (MS), chronic hepatitis B and C, chronic myeloid leukemia, melanoma, renal cell carcinoma, chronic granulomatous disease, and AIDS-related Kaposi's sarcoma.1 Some recombinant interferons are modified with polyethylene glycol groups (i.e., PEGylated) to extend their lifetimes once administered into the bloodstream.2
The market for interferon therapies is expanding, with a compound annual growth rate (CAGR) estimated between 4% and 6%.5-7 This growth is driven by an increasing prevalence of chronic diseases like hepatitis B, hepatitis C, cancer, and MS worldwide, with interferon beta for MS seeing the highest demand surge.5 Interferons are also in development for the treatment of COVID-19, including formulations like peginterferon lambda.6 The sector is further poised for growth through novel combination therapies that integrate interferons with other drug classes.
Similarly, recombinant versions of the hormone erythropoietin (EPO) are utilized to manage anemia (low levels of red blood cells) associated with chronic kidney disease (CKD), certain cancers, and the effects of chemotherapy on the bone marrow.3 These versions, known as erythropoietin stimulating agents (ESAs), include epoetin, darbepoetin, and methoxy polyethylene glycol–epoetin beta.
Conversely, the global erythropoietin market experiences varied growth rates, ranging from 1.5% to 5%.9 The lower growth forecast stems from a market currently dominated by biosimilars.8 Nevertheless, the market for biosimilar and branded erythropoietin drugs is expected to see robust expansion, driven by the rising occurrence of CKD, cancer, hypertension, and diabetes, increased usage of EPO in allogeneic cell therapy, and heightened awareness of the advantages of EPO-based therapies.
Challenges in Accessibility of Interferon and Erythropoietin Therapies
For both interferon and erythropoietin drugs, demand is greatest in western regions including the US and Europe. Although cases of chronic diseases treated with these advanced therapies are rising around the globe, many patients do not have access to these medicines due to their high cost. For instance, the monthly cost for Betaseron® (Bayer) or Rebif® (Merck), two IFN drugs for the treatment of MS, can cost more than $8000 per month before insurance1.
In the United States, factors such as geographical location, health status, racial and educational disparities, and other socioeconomic conditions significantly influence the prescription and usage of ESAs.10 These disparities are even more pronounced in emerging economies, where access issues are compounded.
Globally, approximately 6.5 billion people have limited or no access to biologic drugs. In the United States, where biologics account for 40% of total drug expenditures, only 2% of the population can actually access and afford these treatments.11,12 This stark inequality highlights the urgent need for more accessible healthcare solutions, particularly in the provision of critical biologic therapies.
The Potential Impact of Biosimilars
Biosimilars are biologic drugs designed to be highly similar to their reference biologics in terms of physicochemical properties, pharmacokinetics, safety, and efficacy. The development of biosimilars requires fewer resources and is less costly than their branded counterparts, typically ranging from 15% to 30% of the price of original biologics. Consequently, biosimilars for interferon and erythropoietin could substantially increase the affordability and accessibility of these essential medications.
It's crucial to understand that, despite their lower cost, biosimilars must meet rigorous regulatory standards to ensure their quality and safety. They require comprehensive analytical, preclinical, and clinical data to confirm that there are no clinically meaningful differences from their reference biologics.
Furthermore, regulatory bodies in regions such as the United States, Europe, and Japan have well-established frameworks for biosimilars. Many emerging markets have developed or adopted similar regulations to aid local manufacturers in the efficient navigation of the approval process. This not only helps create a competitive market but also supports healthcare systems and improves patient access to essential treatments.
Overcoming Barriers to Biosimilar Adoption
Streamlining and aligning regulatory approval processes internationally for interferon and EPO biosimilars is crucial, but it is not the only challenge in increasing their uptake, particularly in emerging markets. Another significant barrier is the need to educate both physicians and patients about the availability and safety of these therapies. Misconceptions and a general lack of awareness often lead to reluctance in adopting biosimilars, even when they are readily available.
Education for healthcare providers is essential, as they are pivotal in influencing treatment decisions and can champion the adoption of biosimilars by understanding and sharing their efficacy and safety profiles. Equally critical is patient education to foster acceptance and compliance with biosimilar treatments. This is particularly important in regions where there might already be skepticism towards generic medications, which can extend to biosimilars.
The Impact of Biosidus Biosimilars: Hemax®, Blastoferon®, Escleroferon®, and Bioferon®
Biosidus, a prominent Latin American developer and manufacturer of biosimilars, has made significant strides in the biosimilars market with its range of products, including interferon and EPO biosimilars. The company's portfolio includes nine key biosimilars tailored to meet diverse medical needs, including Hemax® (erythropoietin alfa) and interferons like Blastoferon®, Escleroferon®, and Bioferon®.
Hemax® has had a transformative effect on the treatment of CKD, offering patients a cost-effective alternative to frequent blood transfusions and substantially enhancing their quality of life. Similarly, Biosidus’ interferon biosimilars have become vital in the management of multiple sclerosis and certain cancers, improving patient outcomes and altering the dynamics of the healthcare market by providing more affordable solutions compared with the expensive originator biologics.
These biosimilars have not only improved health outcomes but also dramatically reduced healthcare costs, alleviating the financial strain on healthcare systems and patients. The widespread use of Biosidus’ biosimilars in various regions has led to a significant reduction in the costs associated with managing chronic diseases, highlighting the economic benefits and value of these treatments.
The Biosidus Mission: Pioneering Access to Healthcare through Biosimilars
Biosidus was established with a visionary goal: to bridge the gap between cutting-edge scientific research and practical, accessible healthcare solutions. At the core of this vision is the company's biotechnological platform, designed to produce high-quality biosimilars, affirming the belief that innovative medical treatments should be a universal right rather than a privilege for the few.
To achieve this objective, Biosidus invests in advanced global training and education for its scientific experts, ensuring they remain at the cutting edge of biopharmaceutical innovation. The company's approach is deeply patient-centered, integrating the latest scientific breakthroughs to foster a more equitable healthcare landscape.
Biosidus is also actively working to remove barriers to biosimilar adoption in emerging markets. It implements targeted educational and training programs to build trust among healthcare providers and dispel misconceptions about biosimilars. Furthermore, the company engages in forums and workshops that educate regulatory bodies and help shape biosimilar policies, enhancing the accessibility of affordable biologic treatments. Such strategic initiatives not only improve patient outcomes but also provide cost-effective alternatives that benefit healthcare systems and underscore Biosidus's enduring commitment to global health advancement.
References
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10. Davidoff, Amy J. et al. “Access to Care, Race and Education Are Key Determinants of Erythropoietin Stimulating Agent (ESA) Use In Myelodysplastic Syndromes (MDS).” Blood 116: 3815 (2010).
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