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Teva enters biosimilar commercialisation partnership with Alvotech
pharmaceutical-technology
August 06, 2020
Israel-based Teva Pharmaceutical has formed an exclusive strategic collaboration with Alvotech to commercialise five biosimilar candidates in the US.
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Biocon and Mylan launch fulphila — biosimilar to pegfilgrastim, in Canada
expresspharma
April 29, 2020
The approval of fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
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FDA transitions to new regulatory pathway for biosimilars
europeanpharmaceuticalreview
March 25, 2020
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
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Innovent Out-Licenses Commercial Rights for Avastin® Biosimilar to Coherus BioSciences in the United States and Canada
prnasia
January 15, 2020
Coherus plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in late 2020 or early 2021 depending on FDA interaction timing, and to launch directly upon approval.
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The 2nd Chinese-Produced Adalimumab Biosimilar to be Approved for Marketing
PharmaSources/Xiaoyaowan
January 08, 2020
From the current pattern in China, rather than the price war, Chinese-produced adalimumab biosimilars shall work on at least the following aspects: to strive to enter the NRDL to solve patients’ worries about payment; to strive for more indications to exp
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Important Progresses of New Drugs Marketed in China in 2019
En-CPhI.CN
January 07, 2020
Imported Drugs:1、Novartis CTL019 Applied for Clinical Trial in China to Officially Enter the Chinese Market Novartis f
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WHO announces first biosimilar medicine pre-qualification
europeanpharmaceuticalreview
January 03, 2020
A trastuzumab biosimilar has been pre-qualified by WHO, marking its first, to improve access to the breast cancer treatment.
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Chinese Autoimmune Disease Drug Market: Which of the Competing Global Blockbuster Drugs Will Win?
PharmaSources/1°C
December 05, 2019
Adalimumab has been “active” recently. Multiple adalimumab biosimilars are entering the harvest period in China following the arrival of China’s biosimilar era starting with ...
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Breaking News! China’s Humira Biosimilar Produced by Bio-Thera to be Marketed Soon
PharmaSources/Caicai
November 05, 2019
The marketing application of Bio-Thera’s adalimumab (acceptance No.: CXSS1800018) has recently been under the “under approval” status, which is expected to be approved for marketing soon for treating ankylosing spondylitis (AS).
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Sandoz licences proposed multiple sclerosis biosimilar from Polpharma
pharmaceutical-technology
September 04, 2019
Novartis unit Sandoz has signed an agreement with biopharmaceutical firm Polpharma Biologics for exclusive rights to commercialise a proposed biosimilar of Biogen’s multiple sclerosis drug natalizumab.