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Celltrion Healthcare on Remsima and biosimilars
With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars...
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Biosimilars
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FDA committee recommends approval of Sandoz’s biosimilar etanercept
14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
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Sandoz announces EGALITY trial results for biosimilar etanercept
7 July 2016 | By Victoria White, Digital Content Producer
The EGALITY study involved 531 patients and compared the efficacy and safety of biosimilar etanercept with the originator product, Enbrel...
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Celltrion to develop assay for evidence-based decision-making in anti-TNF treatment
5 July 2016 | By Victoria White, Digital Content Producer
Celltrion is to develop laboratory tests that will enable physicians to identify when patients on an anti-TNF drug require a change of dose...
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Issue #3 2016 – Digital edition
In this issue: Biosimilars, Regulation, Packaging, Microfluidics, Microbiology, PAT, Antibiotic Resistance, and much more...
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Biosimilars – future prospects
Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule…
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Pfizer invests big in biosimilar production in China
28 June 2016 | By Victoria White, Digital Content Producer
Pfizer is to invest $350 million in the development of a state-of-the-art Global Biotechnology Centre in the Hangzhou Economic Development Area...
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Study finds biosimilar switching not suitable for all patients
10 June 2016 | By Victoria White, Digital Content Producer
A study presented at EULAR showed that when antibodies develop in response to the infliximab, they also cross-react with the biosimilar of infliximab...
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Efficacy and safety of Biogen’s anti-TNF biosimilars presented at EULAR
9 June 2016 | By Victoria White, Digital Content Producer
Data demonstrating long-term comparable efficacy, safety and immunogenicity of Benepali (etanercept) and Flixabi (infliximab) have been presented at EULAR...
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Infliximab biosimilar Flixabi approved in the EU
31 May 2016 | By Victoria White, Digital Content Producer
The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade...
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Sandoz acquires rights to biosimilar infliximab in the EEA
12 February 2016 | By Victoria White
Infliximab is a tumour necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
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Tecan simplifies large molecule bioanalysis
Tecan has launched a fully automated affinity purification solution for the extraction of large biomolecules, such as proteins, antibodies and antibody-drug conjugates. This set-up takes advantage of the new Thermo Scientific™ MSIA™ Streptavidin EVO microcolumns, which have been specifically designed for use on Tecan’s proven Freedom EVO® platform. In combination…
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FDA accepts BLA for Amgen’s Humira biosimilar, ABP 501
26 January 2016 | By Victoria White
Humira (adalimumab) is an anti-TNF-α monoclonal antibody which is approved in many regions for the treatment of several inflammatory diseases...
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Real world study demonstrates effectiveness of biosimilar infliximab
6 January 2016 | By Victoria White
Newly presented data from the largest real world study to date demonstrate effectiveness of biosimilar infliximab in patients with inflammatory bowel diseases who have been switched from reference infliximab...
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EMA accepts MAA for Sandoz’s biosimilar etanercept
8 December 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
