Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.
At first, there were associations representing generic drugs, but many expanded their scope, and many new associations and stakeholder groups sprung out quickly.
Without exception, these groups have consistently talked about how biosimilars save money while emphasizing teaching patients and prescribers, all of which enhance the acceptance of biosimilars. These associations collect hundreds of millions of dollars, mainly from the industry, to promote biosimilars. In most cases, the emphasis is on discussing PBMs and other distribution hurdles, but many representatives from these organizations are starting to turn their eyes towards reducing the cost of biosimilar development.1
This is like the era of generics in the early 1980s when the same slogans were raised that generics are saving money. The attention was diverted towards educating stakeholders and pointing out the hurdles in the distributing channels, just as today. Big pharma jumped into generics, seeing that these hurdles can be maintained with the help of generic drug supporters. And then the price drops came, and many big pharma companies were no longer interested.
The only focus all these associations should have is to help harmonize regulatory guidelines—as has already begun to happen— and stop the slogans about how much biosimilars have saved; they are supposed to save. And when the price drops to more than 80%, all other concerns will go away, as will the big pharma.
In the meantime, the millions of dollars spent on advertising, I believe, could be better spent on scientific efforts in educating the regulatory agencies on how to harmonize their guidelines—something no agency is interested in. Our conversations promoting biosimilars need to shift from discussions about their savings, which were destined from the start, to how this market can be sustained for years to come.
References
1. Jeremias S. Uptake barriers will deter future competitors from investing in biosimilars, Julie Reed warns. March 21, 2023. Accessed January 17, 2024. https://www.centerforbiosimilars.com/view/uptake-barriers-will-deter-future-competitors-from-investing-in-biosimilars-julie-reed-warns
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.