A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original...
97 KB (6,513 words) - 22:57, 3 December 2024
Adalimumab (redirect from Adalimumab biosimilar)
Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2022, it was the 241st most commonly prescribed medication...
90 KB (6,884 words) - 04:26, 2 December 2024
novel biologics as well as biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold...
31 KB (2,675 words) - 01:23, 30 November 2024
Infliximab (section Biosimilars)
States in 1998, and in the European Union in August 1999. Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United...
46 KB (4,047 words) - 21:12, 30 June 2024
Group AG is a Swiss company that focuses on generic pharmaceuticals and biosimilars. Prior to October 2023, it was part of a division of Novartis that was...
36 KB (2,804 words) - 02:21, 10 December 2024
"EMA Approves First MAb Biosimilars". BioPharma-reporter.com. "Biosimilar trastuzumab approved in Korea". Generics and Biosimilars Initiative. 17 January...
12 KB (809 words) - 09:31, 17 November 2024
Biopharmaceutical (section Biosimilars)
follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals...
30 KB (2,882 words) - 11:11, 23 July 2024
Aflibercept (section Biosimilars)
It is a biosimilar to Eylea. In August 2024, aflibercept-abzv (Enzeevu) was approved for medical use in the United States. It is a biosimilar to Eylea...
38 KB (2,902 words) - 04:34, 16 December 2024
Ankylosing spondylitis (section Biosimilar drugs)
context of ankylosing spondylitis, biosimilars are typically used as alternatives to the original biologic drugs. Biosimilars for ankylosing spondylitis may...
56 KB (5,994 words) - 00:10, 15 January 2025
Trastuzumab (section Biosimilars)
clinical data demonstrating that Herzuma is biosimilar to US Herceptin. Herzuma has been approved as a biosimilar, not as an interchangeable product. Kanjinti...
70 KB (6,131 words) - 08:28, 27 December 2024
Rituximab (section Biosimilars)
Rituximab Patent". Center for Biosimilars. Retrieved 27 July 2024. "Biosimilars of Rituximab". Generics and Biosimilars Initiative. 14 April 2017. Archived...
62 KB (5,692 words) - 22:59, 18 January 2025
Etanercept (section Biosimilars)
Act of 2009) do have in place a system to approve generic biologics (biosimilars) which "requires mandatory clinical testing and periodic review". In...
33 KB (2,958 words) - 00:23, 12 October 2024
Insulin analog (redirect from Biosimilar insulins)
clear solution as there is no zinc in formula.[better source needed] The biosimilar insulin glargine-yfgn (Semglee) was approved for medical use in the United...
24 KB (3,024 words) - 17:03, 26 December 2024
Filgrastim (section Biosimilars)
the World Health Organization's List of Essential Medicines. Filgrastim biosimilar medications are available. Filgrastim is used to treat neutropenia; acute...
25 KB (1,825 words) - 05:46, 16 December 2024
Insulin glargine (section Biosimilars)
the US Food and Drug Administration (FDA) approved an interchangeable biosimilar insulin product called Semglee (insulin glargine-yfgn) for the treatment...
19 KB (1,547 words) - 07:17, 26 December 2024
Ustekinumab (section Biosimilars)
applicant for this medicinal product is STADA Arzneimittel AG. Uzpruvo is a biosimilar medicinal product. Uzpruvo was authorized for medical use in the European...
42 KB (3,336 words) - 07:12, 27 December 2024
Ranibizumab (section Biosimilars)
September 2021. In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab. In June 2022, the Committee for Medicinal Products for...
35 KB (2,761 words) - 20:52, 10 December 2024
Pharma launches biosimilar in Europe". The Hindu. ISSN 0971-751X. Retrieved 3 October 2021. "Intas Pharmaceuticals launches biosimilar in Europe". The...
14 KB (1,152 words) - 20:14, 28 October 2024
from Sandoz for Jubbonti (denosumab-bbdz), a biosimilar to Prolia; and Wyost (denosumab-bbdz), a biosimilar to Xgeva. In December 2009, the Committee for...
32 KB (2,850 words) - 05:10, 17 December 2024
Bevacizumab (section Biosimilars)
system for biosimilars". BioPharma-Reporter. Archived from the original on 10 January 2016. Retrieved 18 March 2020. "FDA approves first biosimilar for the...
73 KB (6,458 words) - 08:26, 6 December 2024
Tocilizumab (section Biosimilars)
the first tocilizumab biosimilar approved for medical use in the European Union, and in March 2024, became the first biosimilar with both intravenous...
45 KB (3,825 words) - 02:29, 2 January 2025
Teriparatide (section Biosimilars)
Teva Generics has been authorized for marketing in the European Union. Biosimilar product from Gedeon Richter plc has been authorized in the European Union...
27 KB (2,054 words) - 18:54, 16 January 2025
monoclonal antibodies, differ biologically from small-molecule drugs. Biosimilars have active pharmaceutical ingredients that are almost identical to the...
50 KB (5,179 words) - 17:10, 31 December 2024
active pharmaceutical ingredients (APIs), formulations, biologics and biosimilars, and vaccines. Various types of companies are within these segments....
48 KB (4,945 words) - 17:53, 17 January 2025
the biosimilar space has included a 2017 partnership with Adello Biologics (for the collaborative development of Neupogen and Neuasta biosimilars) and...
15 KB (1,189 words) - 20:36, 18 February 2024
name pharmaceutical companies. Its sister company Alvotech produces biosimilars. Alvogen was founded in 2009 by Robert Wessman, who stepped down from...
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developing biosimilars for global markets, including the US and EU. Arven has obtained a marketing authorization in 2016 for the biosimilar of Filgrastim...
10 KB (1,172 words) - 09:36, 14 October 2024
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration...
266 KB (21,122 words) - 16:32, 19 January 2025
ADCs. Samsung Bioepis’s biosimilar product Opuviz has been approved by the European Commission, according to the Korean biosimilar developer on Nov. 2024...
18 KB (1,351 words) - 18:33, 10 January 2025
Ltda. In 2014, Cadila Healthcare launched the world's first adalimumab biosimilar under the brand name Exemptia at one-fifth the originator's price. Zydus...
14 KB (1,148 words) - 05:09, 6 November 2024