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Friday 24 May 2019
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Topic: biosimilars

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.
 

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.
 

January 19, 2018
Marketing authorisation based on global development program showing MVASI is highly similar to Avastin® (bevacizumab)

Amgen and Allergan plc have that the European Commission (EC) has granted marketing authorisation for MVASI® (biosimilar bevacizumab).

 

November 17, 2017
Robust analytical, pharmacological, non–clinical and clinical data demonstrated the similarity of Cyltezo® to Humira®

Boehringer Ingelheim has announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.

November 15, 2017
Kavya Gopal from Sandoz to take-up chair role of Association

The British Biosimilars Association (BBA), the representative group of biosimilar manufacturers in the UK, has announced that Kavya Gopal will become its new chair with immediate effect.

 

Kavya, who is currently Head of the Specialty Business for Sandoz UK, has nearly 20 years of experience in the pharmaceutical industry leading successful teams in the US and in Global roles for Novartis/Sandoz before moving to the UK earlier this year. 

 

November 15, 2017
Kavya Gopal from Sandoz to take-up chair role of Association

The British Biosimilars Association (BBA), the representative group of biosimilar manufacturers in the UK, has announced that Kavya Gopal will become its new chair with immediate effect.

 

Kavya, who is currently Head of the Specialty Business for Sandoz UK, has nearly 20 years of experience in the pharmaceutical industry leading successful teams in the US and in Global roles for Novartis/Sandoz before moving to the UK earlier this year. 

 

June 7, 2017
CT-P6 was similar in efficacy and safety to the reference trastuzumab in a Phase III, double blind, randomised parallel-group study in patients with early breast cancer and HER2 expression

Data presented at the 2017 American Society of Clinical Oncology Annual Meeting has shown similarity in efficacy and safety between CT-P6 (biosimilar trastuzumab candidate) and reference trastuzumab as pre-operative (neoadjuvant) treatment in patients with early breast cancer (EBC) and HER2 overexpression.1

 

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.

 

May 5, 2017
Alternatives to biologic medicines will shake up rheumatoid arthritis sufferers’ treatment regimes

The National Rheumatoid Arthritis Society (NRAS) launched an informative video at the British Society of Rheumatology (BSR) conference to help rheumatoid arthritis sufferers understand upcoming potential changes to their medication.

May 5, 2017
Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers

Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both the biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
 

March 9, 2017
The position paper outlines some of the considerations that are relevent when making a decision to swtich.

EBE, EFPIA and IFPMA have launched a position paper entitled 'Considerations for physicians on switching decisions regarding biosimilars'


Switching describes a physician's decision to exchange one product that a patient receives for another. With the introduction of biosimilars, physicians may be encouraged to switch patients from an original biologic (reference product) to any of its biosimilars (or vice versa) in order to reduce costs.

January 18, 2017
In their position paper published in ESMO Open, the European Society for Medical Oncology outlines the potential benefit of biosimilars to patients and healthcare systems.

January 18, 2017
Boehringer Ingelheim's adalimumab biosimilar candidate to Humira® has been accepted for regulatory review by the EMA and FDA
December 12, 2016
The European Crohn's and Colitis Organisation's latest position paper supports switching from the originator to a biosimilar in patients with IBD.

Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organisation (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab to biosimilar infliximab.1

 

 The ECCO statement covers several aspects related to biosimilars and the key positions are:1

November 16, 2016
Heparins are being used increasingly in new indications, but in introducing its biosimilars to Europe, differences in safety have resulted from differing definitions of biosimilarity throughout the world

Heparins are being used increasingly in new indications, but in introducing its biosimilars to Europe, differences in safety have resulted from differing definitions of biosimilarity throughout the world

 

 

November 16, 2016
Ten years since the first biosimilar was approved in Europe, the benefits in rheumatology are widely acknowledged along with the stringent regulations in place

Ten years since the first biosimilar was approved in Europe, the benefits in rheumatology are widely acknowledged along with the stringent regulations in place

 

 

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.

 

March 22, 2016
Ten independent studies validate the growing bank of real-life clinical evidence to support switching patients from the reference infliximab (Remicade®) to biosimilar infliximab

March 3, 2016
Study will evaluate efficacy, safety and immunogenicity of adalimumab biosimilar candidate MSB11022 compared with Humira®

Merck, a leading science and technology company, announced the initiation of a global Phase III clinical study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis. This milestone is a strong reflection of Merck’s progress in biosimilars, with the goal of delivering high-quality biologics to patients all over the world.
 

March 3, 2016
Study will evaluate efficacy, safety and immunogenicity of adalimumab biosimilar candidate MSB11022 compared with Humira®

Merck, a leading science and technology company, announced the initiation of a global Phase III clinical study of MSB11022, a proposed biosimilar of adalimumab, in chronic plaque psoriasis. This milestone is a strong reflection of Merck’s progress in biosimilars, with the goal of delivering high-quality biologics to patients all over the world.
 

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
     
September 3, 2015
Launch follows March 6, 2015 FDA approval. Sandoz One SourceTM offers patient support services

Sandoz, a Novartis company, announced that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.
 

September 3, 2015
Launch follows March 6, 2015 FDA approval. Sandoz One SourceTM offers patient support services

Sandoz, a Novartis company, announced that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.
 

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