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Thursday 23 May 2019
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Topic: adalimumab

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.

September 18, 2017
Positive opinion follows the recent FDA approval of Cyltezo

Boehringer Ingelheim has  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 Application of Cyltezo® (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.

 

The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

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.

 

January 18, 2017
Boehringer Ingelheim's adalimumab biosimilar candidate to Humira® has been accepted for regulatory review by the EMA and FDA
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.
 

February 25, 2015
The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of biologic therapies for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients. REMICADE® (infliximab), SIMPONI® (golimumab) and HUMIRA® (adalimumab) are recommended, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for such therapies. (1)
June 26, 2008
New guidance has been issued on the use of adalimumab for the treatment of psoriasis

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May 28, 2008
Adalimumab recommended by NICE for the treatment of severe active ankylosing spondylitis

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May 22, 2008
Crohn's patients treated with Humira (adalimumab) achieved long-term remission

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