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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: dupilumab

2022

November 11, 2022

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

November 4, 2022

A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

April 4, 2022

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).

February 22, 2022

Bio-Thera provided an update on its pipeline at the BioPharmaSynergy conference in Amsterdam, reporting that its dupilumab, secukinumab, mepolizumab and vedolizumab biosimilars are in preclinical development.

February 10, 2022

Sanofi announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.  Dupixent was first approved by the FDA in March 2017.

2019

June 27, 2019

The CHMP recommended an extension of the approval of Dupixent® (dupilumab) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent was first approved by the EC in September 2017.

2017

September 28, 2017

Sanofi announced that the EC has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Dupixent was approved by the FDA in March 2017.

May 1, 2017

Plaintiffs Sanofi and Regeneron filed a notice of voluntary dismissal, discontinuing without prejudice the proceedings they commenced in the District Court of Massachusetts in March 2017 in which they were seeking a declaration of non-infringement in relation to Amgen’s Dupixent patent.

March 28, 2017

Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

March 23, 2017

Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487.  The petitioners argue that the ‘487 patent is invalid on novelty grounds.  Earlier this month Sanofi and Regeneron filed a complaint in the District Court of Massachusetts, seeking a declaration of non-infringement.

March 20, 2017

Sanofi-Aventis, Genzyme Corporation and Regeneron filed a complaint in the District Court of Massachusetts seeking a declaration judgement that its development, manufacturing, sale, promotion and related activities for Dupixent® (dupilumab) do/will not directly or indirectly infringe Amgen’s US patent 8,679,487.

2016

December 15, 2016

The results of two Regeneron ph III studies published in the New England Journal of Medicine report that dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, improved the signs and symptoms of atopic dermatitis, symptoms of anxiety and depression, and quality of life, compared with placebo.

BioBlast® extract From December 15, 2016 to November 11, 2022

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Dwyer

Naomi Pearce & Emily Dwyer

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Dwyer, Graduate Lawyer, Trainee Trade Mark Attorney

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