Biosimilars Adoption: Recognizing and Removing the RoadBlocks
Sarfaraz K Niazi College of Pharmacy, University of Illinois, Chicago, IL, 60612, USACorrespondence: Sarfaraz K Niazi, Tel +1-312-297-0000, Email niazi@niazi.comAbstract: Almost two decades since biosimilars arrived, we still await their broader adoption, as anticipated. The roadblocks to this adopt...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-04-01
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| Series: | ClinicoEconomics and Outcomes Research |
| Subjects: | |
| Online Access: | https://www.dovepress.com/biosimilars-adoption-recognizing-and-removing-the-roadblocks-peer-reviewed-fulltext-article-CEOR |
| _version_ | 1797848421339496448 |
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| author | Niazi SK |
| author_facet | Niazi SK |
| author_sort | Niazi SK |
| collection | DOAJ |
| description | Sarfaraz K Niazi College of Pharmacy, University of Illinois, Chicago, IL, 60612, USACorrespondence: Sarfaraz K Niazi, Tel +1-312-297-0000, Email niazi@niazi.comAbstract: 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: biosimilars, biosimilarity, development cost, regulatory planning, accessibility, affordability, FDA, EMA, WHO, MHRA |
| first_indexed | 2024-04-09T18:28:22Z |
| format | Article |
| id | doaj.art-12c05f47effb4c97a92ee6154cd1ae1e |
| institution | Directory Open Access Journal |
| issn | 1178-6981 |
| language | English |
| last_indexed | 2024-04-09T18:28:22Z |
| publishDate | 2023-04-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | ClinicoEconomics and Outcomes Research |
| spelling | doaj.art-12c05f47effb4c97a92ee6154cd1ae1e2023-04-11T19:04:59ZengDove Medical PressClinicoEconomics and Outcomes Research1178-69812023-04-01Volume 1528129482958Biosimilars Adoption: Recognizing and Removing the RoadBlocksNiazi SKSarfaraz K Niazi College of Pharmacy, University of Illinois, Chicago, IL, 60612, USACorrespondence: Sarfaraz K Niazi, Tel +1-312-297-0000, Email niazi@niazi.comAbstract: 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: biosimilars, biosimilarity, development cost, regulatory planning, accessibility, affordability, FDA, EMA, WHO, MHRAhttps://www.dovepress.com/biosimilars-adoption-recognizing-and-removing-the-roadblocks-peer-reviewed-fulltext-article-CEORbiosimilarsbiosimilaritydevelopment costregulatory planningaccessibilityaffordabilityfdaemawhomhra |
| spellingShingle | Niazi SK Biosimilars Adoption: Recognizing and Removing the RoadBlocks ClinicoEconomics and Outcomes Research biosimilars biosimilarity development cost regulatory planning accessibility affordability fda ema who mhra |
| title | Biosimilars Adoption: Recognizing and Removing the RoadBlocks |
| title_full | Biosimilars Adoption: Recognizing and Removing the RoadBlocks |
| title_fullStr | Biosimilars Adoption: Recognizing and Removing the RoadBlocks |
| title_full_unstemmed | Biosimilars Adoption: Recognizing and Removing the RoadBlocks |
| title_short | Biosimilars Adoption: Recognizing and Removing the RoadBlocks |
| title_sort | biosimilars adoption recognizing and removing the roadblocks |
| topic | biosimilars biosimilarity development cost regulatory planning accessibility affordability fda ema who mhra |
| url | https://www.dovepress.com/biosimilars-adoption-recognizing-and-removing-the-roadblocks-peer-reviewed-fulltext-article-CEOR |
| work_keys_str_mv | AT niazisk biosimilarsadoptionrecognizingandremovingtheroadblocks |