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4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
Sartorius Stedim Biotech (SSB) BioOutsource today announced its expert technical staff will be speaking at and/or attending BIOLATAM, Biosimilars LATAM and Biosimilars and Biobetters conferences from November 16-19. This will provide developers of biosimilars with an excellent opportunity to discuss the optimum assay design for rapid and accurate biosimilar characterisation…
10 November 2015 | By Victoria White
CHS-0214 met its primary endpoints in a Phase 3 study in patients with moderate-to-severe chronic plaque psoriasis...
10 November 2015 | By Victoria White
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases...
28 October 2015 | By Victoria White
New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease are switched to biosimilar infliximab Remsima from originator infliximab...
25 September 2015 | By Victoria White
The British Generic Manufacturers Association, the Association of the British Pharmaceutical Industry (ABPI), and the UK BioIndustry Association (BIA) have joined forces to welcome NHS England’s new publication “What is a biosimilar medicine?”.
24 September 2015 | By Victoria White
ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb)...
17 September 2015 | By Victoria White
BioInject will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics...
15 September 2015 | By Victoria White
Data from secondary analyses of Phase III trials show Abasaglar (insulin glargine) demonstrated safety and efficacy outcomes similar to Lantus in diabetes...
27 July 2015 | By Victoria White
CPhI Korea, organised by UBM EMEA, will return to the COEX in Seoul, South Korea – 7 to 9 September 2015 – following a successful inaugural event last year...
30 June 2015 | By Victoria White
The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, according to GBI Research...
The British Generic Manufacturers Association (BGMA) will stage the next meeting of its Quality Forum – in conjunction with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) - on Wednesday, July 8th.
6 March 2015 | By GlobalData
“AbbVie’s acquisition of Pharmacyclics (PCYC), valued at $21 billion, will help the company alleviate its dependency on Humira, which accounted for 62% of its total revenues in 2014, up from 57% in 2013..."
25 February 2015 | By British Generic Manufacturers Association
The onset of biosimilar competition in the UK in Infliximab is another significant milestone in the development of the sector in this country according to the British Generic Manufacturers Association (BGMA).
