BREAKING BARRIERS TO TREATMENT
Biologics make up just 5-10% of global medicine sales by volume but represent a staggering 25% of the market’s value. These complex and costly molecules are essential for treating chronic, rare, and oncologic conditions. This makes biosimilars, by driving down costs, critical to improving treatment accessibility and ensuring the sustainability of healthcare systems worldwide.
Like the early days of generic medicines, biosimilars initially faced skepticism, with concerns about their safety and efficacy. A decade later, with rigorous comparability studies, well-established regulatory frameworks, and billions of patients treated globally, the landscape has shifted. Yet, surveys (1,2) still reveal that many doctors lack awareness of biosimilars‘ equivalence to their reference innovators.
So, if the science is clear and regulatory frameworks are in place, what continues to hold back widespread adoption?
Eduardo Cioppi, our Global Commercial Director, brings 33 years of experience in biopharmaceuticals and a deep understanding of global markets. Through his insights and experience expanding mAbxience’s worldwide reach, we can better understand the shifting biosimilar landscape and explore how companies, regulators, and healthcare stakeholders can work together to foster education and accelerate adoption. And ultimately, break down barriers to treatment.
A regulatory system in transition
While both the FDA and EMA have made significant strides in updating approval guidelines for biosimilars, further adjustments are necessary to eliminate redundant studies and streamline the process. The impeccable safety and efficacy record of biosimilars over the past 20 years is strong evidence that these regulatory agencies will continue to evolve their policies. However, for biosimilars to reach their full potential, the approval process must become more accessible to small and medium-sized companies, fostering competition and innovation.
The cost of biosimilar development remains a key challenge. Estimates range from $30 million for products not requiring Phase III studies to over $50 million for those that do, particularly in oncology (3). However, with advancements in analytical technologies capable of detecting even the most minute differences between biosimilars and their reference products, there is a strong case for reducing the need for expensive clinical trials. If regulatory agencies continue to refine approval pathways based on these scientific advancements, the cost burden could drop significantly, allowing more players to enter the market.
Yet, even if regulatory challenges are addressed, another formidable obstacle remains:
The complexities of market distribution
Despite regulatory progress, the reality is that many biosimilars struggle to gain traction due to entrenched market structures. In the U.S., Pharmacy Benefit Managers (PBMs) hold immense influence over pricing and formulary decisions, often favoring higher-cost branded biologics over biosimilars.
In the EU, the bureaucratic inefficiencies surrounding tender-based procurement have led to inconsistent outcomes. While some countries have successfully integrated biosimilars into their healthcare systems, others continue to face pricing and accessibility challenges due to fragmented policies.
But even with the right policies and distribution frameworks in place, one fundamental challenge remains:
“There is a lot of education to be done.”
Can education unlock the full potential of biosimilars in healthcare?
We are proud of our commitment to working closely with everyone involved in the healthcare ecosystem. Our openness and flexibility, combined with the ability to adapt to different environments, set mAbxience apart and fuel our success in bringing affordable biosimilars to patients worldwide.
Our stakeholders aren’t just the buyers, “they are the patients, the patients’ families, the nurses, doctors, regulatory agencies…” Building trust and education across all involved parties is essential. The real challenge, as Cioppi notes, is understanding the unique needs of each local market and forging strong relationships with stakeholders. Only by doing so can we demonstrate that biosimilars are just as safe and effective as their reference biologics.
While the path to widespread biosimilar adoption is becoming clearer, many challenges remain. And as we continue to expand access, how can we ensure that every patient, regardless of location, benefits from these treatments?
These are the questions that will guide our journey forward. In our next blog, we’ll dive deeper into the regulatory changes and market shifts that have played a pivotal role in this paradigm shift. We’ll explore how these changes have influenced the adoption of biosimilars and what lies ahead in the evolving landscape. Stay tuned as we unpack the ongoing transformation of the biosimilars market and look ahead to the next chapter in the fight for greater treatment accessibility.
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References:
(1) Cohen H, Beydoun D, Chien D, Lessor T, McCabe D, Muenzberg M, Popovian R, Uy J. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther. 2017 Jan;33(12):2160-2172. doi: 10.1007/s12325-016-0431-5. Epub 2016 Oct 31. PMID: 27798772; PMCID: PMC5126187.
(2) Thongpooswan S, Das A, Patil P, Latymer M, Llamado L, Wee J. Physicians’ and patients’ perception of biosimilars and factors affecting biosimilar prescribing in selected Asian countries: a survey study. Expert Opin Biol Ther. 2024 Oct;24(10):1171-1182. doi: 10.1080/14712598.2024.2400523. Epub 2024 Sep 17. PMID: 39234698.
(3) Niazi SK. Biosimilars Adoption: Recognizing and Removing the RoadBlocks. Clinicoecon Outcomes Res. 2023 Apr 12;15:281-294. doi: 10.2147/CEOR.S404175. PMID: 37077364; PMCID: PMC10106314.
