ICAR Research Data Repository for Knowledge Management
Legal Pathways for Biosimilar: Comparison of Legal Rules in Different Countries
NOPR - NISCAIR Online Periodicals Repository
View Archive Info| Field | Value | |
| Title |
Legal Pathways for Biosimilar: Comparison of Legal Rules in Different Countries
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| Creator |
Priyarega, Sivakumar
Natarajan, Ramanathan |
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| Subject |
Biosimilar,
Biologics, Reference Product Sponsor (RPS) Abbreviated Biologic Licence Application (aBLA) Patent Dance Patent Linkage United States Food and Drug Administration (USFDA) |
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| Description |
407-412
The generics of biologic drugs play a significant role in pharmaceutics and therapeutics owing to their affordability to a group of patients with fatal diseases. Even though the challenges in manufacturing of these drugs are overcome by biosimilar applicants, the disputes on patents hamper the market entry of biosimilar. The countries such as United States, European Union, Japan, Canada etc. follow divergent legal pathways to avoid these conflicts. In this article, the patent dancing in US and patent linkage systems in various countries are elaborated. As for India, few generic manufacturers attempted to resolve patent disputes through lawsuits, yet no patent linkage system is established by legislation. |
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| Date |
2024-09-06T06:18:33Z
2024-09-06T06:18:33Z 2024-09 |
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| Type |
Article
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| Identifier |
0975-1076 (Online); 0971-7544 (Print)
http://nopr.niscpr.res.in/handle/123456789/64473 https://doi.org/10.56042/jipr.v29i5.3838 |
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| Language |
en
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| Publisher |
NIScPR-CSIR,India
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| Source |
JIPR Vol.29(5) [September 2024]
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