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Monday 27 May 2019
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Topic: mAbs

May 31, 2017
Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira and Remicade

Sandoz has announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab) both of which are used to treat immunological diseases.

 

Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.

 

September 25, 2015
Daratumumab is for treatment of European patients with heavily pre-treated multiple myeloma

Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). This acceptance follows the earlier regulatory submission of a MAA, which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory, multiple myeloma and is currently pending validation by the EMA.
 

September 9, 2015
Daratumumab is for European patients with heavily pre-treated multiple myeloma

Janssen-Cilag International NV announced it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for daratumumab, an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma.
 

June 26, 2015
Adults with non-radiographic axial spondyloarthritis can be considered for once-monthly subcutaneous injection with SIMPONI® (golimumab)

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) announced that on 22 June the European Commission approved SIMPONI® (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). This follows CHMP positive opinion issued in May 2015, (1) based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with SIMPONI®, compared with patients treated with placebo, over 16 weeks. (2)

 

June 10, 2015
The comparable safety and efficacy of switching patients to a biosimilar anti-TNF-alpha monoclonal antibody from the reference medicinal product (RMP) has been further established in data presented at EULAR 2015, the annual meeting of the European League Against Rheumatism. Data from abstracts published or presented at the conference show that the effectiveness of biosimilar infliximab CT-P13, developed and manufactured by Celltrion, Inc., was similar to the RMP in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients who were switched from the RMP to the biosimilar infliximab, with no additional safety signals. (1)
March 3, 2015
• The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications • Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy • Biosimilar monoclonal antibodies are expected to save European healthcare systems between €1.8 and €20.4 billion between 2007 and 2020 (1)

•    The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications
•    Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy

March 3, 2015
• The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications • Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy • Biosimilar monoclonal antibodies are expected to save European healthcare systems between €1.8 and €20.4 billion between 2007 and 2020 (1)

•    The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications
•    Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy

February 20, 2015
Celltrion Healthcare has announced data demonstrating the healthcare savings achievable by using Remsima™ (CT-P13), a biosimilar monoclonal antibody infliximab, to treat patients with Crohn’s disease (CD) in France, Italy and the UK. (1)

Celltrion Healthcare has announced data demonstrating the healthcare savings achievable by using Remsima™ (CT-P13), a biosimilar monoclonal antibody infliximab, to treat patients with Crohn’s disease (CD) in France, Italy and the UK. (1)

 

 

February 20, 2015
Ferring Pharmaceuticals announced the European launch of CORTIMENT®MMX® (budesonide), the first and only approved oral controlled release budesonide treatment for active mild-to-moderate ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not sufficient.

Ferring Pharmaceuticals announced the European launch of CORTIMENT®MMX® (budesonide), the first and only approved oral controlled release budesonide treatment for active mild-to-moderate ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not sufficient.

 

 

August 15, 2014
Mundipharma International Corporation Limited has announced that it has secured a distribution licence from Celltrion Healthcare Hungary Kft for Remsima (infliximab).

Mundipharma International Corporation Limited has announced that it has secured a distribution licence from Celltrion Healthcare Hungary Kft for RemsimaTM (infliximab).

Following expiry of the relevant patents and Supplementary Protection Certificate’s, Mundipharma and its independent associated companies will have exclusive rights to market Remsima in the UK, Germany, Italy, Belgium, Luxembourg and the Netherlands.

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