All Biosimilar articles
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BusinessUS supreme court ends Sandoz–Amgen biosimilar dispute
Sandoz’s copy of arthritis drug Enbrel won’t be available in the US until 2029, 30 years after it was first marketed
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BusinessPharmaceuticals roundup 2019
Under the shadow of political turmoil and major lawsuits, the industry returned to its strengths – making new drugs, and finding new ways to do it better
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BusinessUS finalises guidance on biosimilars
Regulator clarifies requirements for allowing substitution between products
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BusinessAmgen partners to launch biosimilars in China
US biopharma and Chinese generics firm will co-develop medicines from Amgen’s pipeline focused on inflammation and oncology
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BusinessUS court denies Amgen appeal over Pfizer biosimilar
Amgen has lost its bid to compel Pfizer to divulge information about its version of anaemia drug Epogen
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NewsLegal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
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BusinessIndia probes Roche over biosimilars
Mylan and Biocon claim Roche abused its market dominance to quash generic breast cancer antibodies
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BusinessFresenius to buy Akorn and Merck KGaA’s biosimilars
Deals give Fresenius entry into rapidly growing biological drugs market
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NewsPfizer launches new biosimilar drug in US
Autoimmune disease treatment becomes only the second biosimilar to be approved by the FDA
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BusinessNovo Nordisk to axe 1000 jobs
Diabetes specialist is cutting costs in the face of increased competition
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BusinessSanofi sues Merck & Co over biosimilars
Merck challenges insulin patents, but Sanofi claims infringement
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Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
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Business
Injunction blocks first US biosimilar
Despite regulatory approval, Amgen is delaying sales of Sandoz’s version of filgrastim
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Business
US approves biosimilar filgrastim
Sandoz’s version of Amgen’s Neupogen is ‘biosimilar’ but not ‘interchangeable’
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BusinessUS poised to approve its first ‘biosimilar’ drug
FDA panel recommends Sandoz’s copy of Amgen’s Neupogen
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Business
Inhaled insulin approved in US
European committee recommends approval for generic long-acting insulin
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Business
First biosimilar antibody drugs approved in Europe
European commission gives final approval to generic infliximab copies
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Business
Biosimilar drugs step up complexity
First generic monoclonal antibodies recommended for approval in Europe