Creating China’s Biosimilar Drugs Regulatory System: A Calculated Approach

Yang, Jianhong; Zhao, Xiaoyu; Jie, Li; Zhang, Kejian; Zhang, Zheru; Chang, Shunwen; Fu, Daotian; Lyu, Xinhuan; Zhang, Xianglin; Shen, Ying

doi:10.3389/fphar.2022.815074

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2023

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“…However, the need for a sound regulatory path for hundreds of biosimilars developed in China 73 will keep them from entry into the US. 74 Until China adopts globally harmonizing guidelines for biosimilars. The FDA has also struck other non-US competitors like Alvotech, 75 reducing the number of potential competitors.…”

Section: Competitionmentioning

confidence: 99%

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Niazi¹

2023

CEOR

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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.

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Section: Competitionmentioning

confidence: 99%

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Niazi¹

2023

CEOR

View full text Add to dashboard Cite

show abstract

Creating China’s Biosimilar Drugs Regulatory System: A Calculated Approach

Cited by 1 publication

References 12 publications

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

Biosimilars Adoption: Recognizing and Removing the RoadBlocks

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