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. 2023 Apr 12:15:281-294.
doi: 10.2147/CEOR.S404175. eCollection 2023.

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Sarfaraz K Niazi  1
Affiliations

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Sarfaraz K Niazi. Clinicoecon Outcomes Res. .

Abstract

Almost two decades since biosimilars arrived, we still await their broader adoption, as anticipated. The roadblocks to this adoption include the high amortized cost of goods due to regulatory burden, hurdles created by the distribution system, perception of safety and efficacy, and lack of focus by stakeholders on removing these roadblocks. In this paper, I analyze the source of these roadblocks and offer practical solutions to remove them. These efforts are needed to maximize the adoption of biosimilars to encourage the entry of 100+ biological molecules that can bring affordable healthcare direly missing today across the globe.

Keywords: EMA; FDA; MHRA; WHO; accessibility; affordability; biosimilarity; biosimilars; development cost; regulatory planning.

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Conflict of interest statement

The author declares no conflict of interest.

Figures

Figure 1
Figure 1
Comparison of market share as a percentage of units contributed by biosimilars with the discount from the price of the reference product in 24 European countries and the US. European data [https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-Europe-2021.pdf]. US data [Barclay Global Pharmaceuticals; US Specialty Pharma. September 2022.] The US data are based on filgrastim, pegfilgrastim, trastuzumab, infliximab, and bevacizumab products till the third quarter of 2022.
Figure 2
Figure 2
WAC Percent reduction of the biosimilars in the US. The WAC does not include gross-net sale discounts. [Source: https://www.iqvia.com; https://www.cms.gov].
Figure 3
Figure 3
Comparison of percent reduction of WAC price and percent adoption of biosimilars in the US. WAC Price does not include GTN discounts. The reference product is scored as 1.0.
Figure 4
Figure 4
The four reins are pulling back the adoption of biosimilars and artwork created by the Open AI platform, DALLE-2. (https://openai.com/product/dall-e-2).
See this image and copyright information in PMC

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