FDA regulates biologicals, which are the fastest-growing class of medications in the US. These drugs offer hope and treatment to millions of Americans, but they can be expensive. To address this issue, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated approval pathway to provide patients with access to safe and effective biosimilars. Biosimilars are highly similar to FDA-approved biologicals (reference products) and can potentially reduce costs for patients and the healthcare system through market competition.

FDA and the FTC have been working together to advance competition for biologicals. There are many roadblocks that can delay competition, such as patent thickets, which are groups of overlapping patents that can hinder the development and availability of biosimilars. FDA and the FTC are working to combat activities that undermine competition and/or harm public health.

The commitments of the FTC and FDA, describing their efforts to work together to promote competitive markets for biological product, are issued in the Joint Statement of the Food & Drug Administration and the Federal Trade Commission Regarding a Collaboration to Advance Competition in the Biologic Marketplace.FDA and the FTC also drafted a summary report of a joint public workshop on a Competitive Marketplace for Biosimilars held on March 2020. 

The agencies also share concerns about false or misleading information and their negative impacts on public health and drug competition. To address this issue, FDA and the FTC have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions. Unbiased information can help patients and their providers understand the treatment options available.

There are 43 biosimilars that have been approved by FDA [1], and 27 of them are currently available on the market. Additionally, there are more than 100 biosimilars in development for over 50 different reference products. The goal of FDA and the FTC is to support and advance healthy market competition and accurate information about biosimilars.

The US and Europe have a number of key differences in the way in which they approve biosimilar drugs. Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes [2].

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References 
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
2. Biosimilars markets: US and EU compared. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):90-2. doi:10.5639/gabij.2020.0902.015

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