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Sep 27, 2024
On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA. The European approval is for moderately to severely active Crohn’s...
Sep 27, 2024
On 27 September, AbbVie announced that it submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor...
Sep 26, 2024
In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of...
Sep 25, 2024
On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz). The results, presented at the European Academy of Dermatology and Venereology (EADV), reportedly show that more than 80% of adults and...
Sep 25, 2024
On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma...
Sep 25, 2024
On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam. The first set of data is results from a Phase 3 study...
Sep 25, 2024
On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis. In August 2024, Intas Pharmaceutical received approval from India’s Central Drug...
Sep 24, 2024
On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with Janssen's Stelara® that is manufactured using a CHO cell-line system, until the FDA has evaluated...
Sep 23, 2024
On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September...
Sep 23, 2024
On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the...
Sep 23, 2024
On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis. UCB reports that...
Sep 20, 2024
On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not...
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