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Thursday 23 May 2019
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Topic: biosimilar

May 4, 2018
Herzuma is the third biosimilar to be marketed and distributed by the Mundipharma network in Europe

The Mundipharma global network of independent associated companies has announced that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months.
 

The Mundipharma network has exclusive distribution rights to Herzuma
in the UK, Germany, Italy, Ireland, Belgium, Luxembourg and the Netherlands.
 

March 26, 2018
Positive opinion for ABP 980 is supported by Phase III data in patients with HER2-postive early breast cancer

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of ABP 980, a biosimilar to Herceptin® (trastuzumab).

 

March 8, 2018
Ontruzant is the first breast cancer biosimilar to be launched in the UK, and is the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd

MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

 

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.1

 

February 19, 2018
PANTS study shows that CT-P13 is an efficacious therapy option when investigating personalised approaches to anti-TNF therapy

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO).

 

The results indicate that the clinical effectiveness, safety and immunogenicity of Pfizer and Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1

 

February 15, 2018
Herzuma® (CT-P6) granted EU marketing authorisation to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer

Celltrion Healthcare has announced that the European Commission (EC) has approved Herzuma® (trastuzumab biosimilar, CT-P6) for all indications of reference trastuzumab in the European Union (EU).

 

The approval of Herzuma® marks the third Celltrion Healthcare product approved in the EU and builds on the company’s expanding biosimilar portfolio.
 

November 10, 2017
ABP 215 is being developed as a biosimilar to bevacizumab

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation of ABP 215, a biosimilar to Avastin® (bevacizumab).

 

November 9, 2017
48-week Phase III data showed Cyltezo® and Humira® have similar efficacy, safety and immunogenicity in people with rheumatoid arthritis

Boehringer Ingelheim has announced one-year data from Voltaire®-RA, a pivotal Phase III clinical trial comparing Cyltezo® (adalimumab-adbm) and reference product Humira®.

 

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.

 

February 27, 2017
Truxima has been approved for use in all indications of the reference product Mabthera, based on its preclinical, safety and efficacy data

Celltrion Healthcare has announced that the European Commission has approved TruximaTM (biosimilar rituximab) for all indications of reference rituximab in the European Union (EU).

 

Truxima™ is the first biosimilar monoclonal antibody (mAb) approved in an oncology indication worldwide. The approval of Truxima™ builds on Celltrion Healthcare’s strong global clinical biosimilar programme.

 

July 7, 2016
As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate in psoriasis

Sandoz has announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met.

 

The study compared the safety and efficacy of its biosimilar etanercept candidate with the originator product, Enbrel® in patients with moderate-to-severe chronic plaque-type psoriasis and was presented at Psoriasis 2016, the 5th Congress of the Psoriasis International Network (PIN), Paris, France.

 

January 11, 2016
In a study of 397 patients with ulcerative colitis and Crohn’s disease, 93 patients (23%) were switched to a biosimilar infliximab from the reference infliximab, representing the largest group of switch patients studied to date in inflammatory bowel diseases
  • In a study of 397 patients with ulcerative colitis and Crohn’s disease, 93 patients (23%) were switched to a biosimilar infliximab from the reference infliximab, representing the largest group of switch patients studied to date in inflammatory bowel diseases (IBD)1
     
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

November 18, 2009
Teva UK Limited has signalled its commitment to developing biosimilar medicines by entering the G-CSF therapy area

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February 13, 2009
Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union

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January 14, 2009
European Medicines Agency approves biosimilar

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September 15, 2008
Data at ESMO conference shows retacrit to be an effective treatment for chemotherapy-induced anaemia.

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June 9, 2008
EGA report identifies patent-related barriers to affordable generic medicines

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May 12, 2008
Retacrit demonstrates equivalent efficacy, safety and tolerability to Epoetin Alfa

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April 4, 2008
A collaboration between Austrian and Indian firms brings neutropenia treatment through a phase I trial

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February 25, 2008
CHMP, the scientific committee of the European Medicines Agency (EMEA), has given a positive opinion regarding a biosimilar human granulocyte colony stimulating factor (G-CSF) product

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