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BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars

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Article

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.

Organization

Description

Focuses on policies for generic and biosimilar medicine access.

A division of AAM promoting biosimilars as cost-effective alternatives.

Advocates for patient access to biosimilars in the US

Global representation for generic and biosimilar medicines.

Advocates for safe and effective use of biologics and biosimilars.

Promotes biosimilar adoption in Canada.

Represents the generic and biosimilar medicine industries in Europe.

Provides resources on the cost-saving potential of biosimilars.

Educates and promotes biosimilar adoption in Australia.

A platform for biosimilar industry insights and developments.

Advocates for improving access to biologics through biosimilars.

Provides educational resources on biosimilars for patient organizations.

Offers information to patients about biosimilar medicines.

An annual event focusing on regulatory science and policy for the US generics and biosimilars industry.

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

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