Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals
Biopharmaceuticals exhibit excellent therapeutic efficacy; however, their high cost remains a significant limitation. The introduction of biosimilars is expected to enhance market competition and reduce biopharmaceutical prices. As of January 2025, Europe has approved 92 biosimilars for 25 reference...
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| Format: | Article |
| Language: | English |
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Korea Institute of Intellectual Property
2025-06-01
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| Series: | Journal of Intellectual Property |
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| Online Access: | https://jip.or.kr/2002-01/ |
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| author | Tae-Kwon Kim Tai-Hyun Kang |
| author_facet | Tae-Kwon Kim Tai-Hyun Kang |
| author_sort | Tae-Kwon Kim |
| collection | DOAJ |
| description | Biopharmaceuticals exhibit excellent therapeutic efficacy; however, their high cost remains a significant limitation. The introduction of biosimilars is expected to enhance market competition and reduce biopharmaceutical prices. As of January 2025, Europe has approved 92 biosimilars for 25 reference biopharmaceuticals since the first biosimilar launch in 2006, contributing substantially to price reductions. In contrast, although the US FDA has approved 64 biosimilars for 17 reference products since 2015, their market uptake remains limited, and the resulting price reductions have been minimal. Two primary hypotheses have been proposed to explain this disparity: (1) biosimilar entry is hindered by complex patent landscapes and litigation initiated by originator companies, and (2) structural differences in biosimilar-related regulatory frameworks between the United States and Europe influence market dynamics. In this study, we examine key patent filings and litigation histories for Humira and Remicade, alongside biosimilar sales trends and pricing in both the United States and Europe following expiration of substance patents. Furthermore, by comparing current regulatory frameworks, including approval pathways, prescribing practices, and policies on interchangeability and substitution, we identify factors that have promoted biosimilar adoption in Europe and explore implications for encouraging biosimilar uptake in Korea. |
| format | Article |
| id | doaj-art-9b29cd09d02c45a593278fa9717d3e19 |
| institution | DOAJ |
| issn | 1975-5945 2733-8487 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Korea Institute of Intellectual Property |
| record_format | Article |
| series | Journal of Intellectual Property |
| spelling | doaj-art-9b29cd09d02c45a593278fa9717d3e192025-08-20T02:41:34ZengKorea Institute of Intellectual PropertyJournal of Intellectual Property1975-59452733-84872025-06-0120212910.34122/jip.2025.20.2.1Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α BiopharmaceuticalsTae-Kwon Kim0https://orcid.org/0009-0003-0199-0392Tai-Hyun Kang1https://orcid.org/0009-0000-9197-959XPh. D., Senior Researcher, Korea Institute of Intellectual Property Promotion, Republic of KoreaPh. D., Fourth Grade Official of Science and Technology, Korean Intellectual Property Office, Republic of KoreaBiopharmaceuticals exhibit excellent therapeutic efficacy; however, their high cost remains a significant limitation. The introduction of biosimilars is expected to enhance market competition and reduce biopharmaceutical prices. As of January 2025, Europe has approved 92 biosimilars for 25 reference biopharmaceuticals since the first biosimilar launch in 2006, contributing substantially to price reductions. In contrast, although the US FDA has approved 64 biosimilars for 17 reference products since 2015, their market uptake remains limited, and the resulting price reductions have been minimal. Two primary hypotheses have been proposed to explain this disparity: (1) biosimilar entry is hindered by complex patent landscapes and litigation initiated by originator companies, and (2) structural differences in biosimilar-related regulatory frameworks between the United States and Europe influence market dynamics. In this study, we examine key patent filings and litigation histories for Humira and Remicade, alongside biosimilar sales trends and pricing in both the United States and Europe following expiration of substance patents. Furthermore, by comparing current regulatory frameworks, including approval pathways, prescribing practices, and policies on interchangeability and substitution, we identify factors that have promoted biosimilar adoption in Europe and explore implications for encouraging biosimilar uptake in Korea.https://jip.or.kr/2002-01/biosimilarsanti-tnf-α therapiespatentsmarket dynamicsregulatory policy |
| spellingShingle | Tae-Kwon Kim Tai-Hyun Kang Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals Journal of Intellectual Property biosimilars anti-tnf-α therapies patents market dynamics regulatory policy |
| title | Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals |
| title_full | Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals |
| title_fullStr | Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals |
| title_full_unstemmed | Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals |
| title_short | Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals |
| title_sort | patent and regulatory landscape of biosimilars in the united states and europe implications for advancing the domestic biosimilar industry with a focus on anti tnf α biopharmaceuticals |
| topic | biosimilars anti-tnf-α therapies patents market dynamics regulatory policy |
| url | https://jip.or.kr/2002-01/ |
| work_keys_str_mv | AT taekwonkim patentandregulatorylandscapeofbiosimilarsintheunitedstatesandeuropeimplicationsforadvancingthedomesticbiosimilarindustrywithafocusonantitnfabiopharmaceuticals AT taihyunkang patentandregulatorylandscapeofbiosimilarsintheunitedstatesandeuropeimplicationsforadvancingthedomesticbiosimilarindustrywithafocusonantitnfabiopharmaceuticals |