On 27 September 2024, Sanofi and Regeneron announced that Dupixent® (dupilumab) has been approved in the US as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.  On the same date, the companies announced that China’s National Medical Products Administration (NMPA) has approved Dupixent® for the same indication. This follows the UK approval of Dupixent® as an add-on maintenance treatment for COPD earlier this month. In July 2024, Dupixent® received European approval as an add-on maintenance tre ..read more

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease and ulcerative colitis. This is the second approval for a Pfizer-sponsored infliximab biosimilar, with Inflectra® having been the first infliximab biosimilar approved in Australia in November 2015. On 26 September 2024, the TGA provisionally approved Janssen’s ..read more

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 disease, moderate to severe plaque psoriasis and active psoriatic arthritis, while the US approval is for the same indications with the addition of ulcerative colitis. Otulfi®/FYB202 is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fres ..read more

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 ustekinumab for treating ulcerative colitis, is invalid. The matter involves litigation brought by Samsung Bioepis seeking to invalidate the Janssen patent on the grounds of novelty and obviousness.  Janssen counter-claimed against Samsung Bioepis for patent infringement.  On 30 July 2024, Justice Meade issued a decision in Sams ..read more

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 adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss™ at week 16 and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing.  The results are also reported to show that nearly 87% of patients did not require high-potency topical corticosteroids or ..read more

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 (NSCLC).  This NSCLC indication approval is based on results from the Phase 3 KEYNOTE-671 trial and follows approvals for the same indication in the EU (March 2024) and US (October 2023). On the same date, MSD announced that Keytruda® has also been approved in Japan as monotherapy for patients with radically unresectable uroth ..read more

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 comparing the efficacy, safety, immunogenicity, and pharmacokinetics of Biocon’s Bmab 1200 (bUstekinumab), with Janssen’s Stelara® (ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis.  The results are said to show biosimilarity between Bmab 1200 and Stelara®. In May 2024, Biocon announced that the FDA ..read more

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 Standard Control Organisation (CDSCO) to conduct a Phase 3 clinical study of its vedolizumab biosimilar, INTP53.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®. Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerati ..read more

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 in Barcelona. Celltrion reports that the Phase 3 trial showed that Eydenzelt™ has comparable efficacy and safety to Eylea® over 52 weeks in patients with diabetic macula oedema (DME). Eydenzelt™ was approved in Korea in May 2024.  Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed ..read more

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 US.  The order is currently under seal. On the same date, Regeneron filed an appeal from the preliminary injunction determination. The proceeding against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (aBLA for ABP 938/Pavblu™ ac ..read more