Pearce IP BioBlast w/e 16 Feb 2024

Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.  The announcement states that Xolair® is the first FDA-approved medicine to reduce allergic reactions in people with food allergies.  The approval was based on the Phase III OUtMATCH study in patients allergic to peanuts and at least two other food allergens.  Xolair was previously FDA approved for the treatment of asthma, chronic rhinosinusitis and chronic spontaneous urticaria.  

Parent company Roche announced submission of the BLA for the food allergy indication in December 2023.  Celltrion, Glenmark and Kashiv Biosciences are reported to have omalizumab biosimilars in development. 

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a phase 3 trial showing Dupixent® significantly reduced itch severity compared to placebo.  

Last month, FDA approved a new indication of Dupixent® (dupilumab) for the treatment of paediatric patients with eosinophilic esophagitis. 

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions.  AVT04 received regulatory approval in January 2024 in Europe, in September 2023 in Japan and in November 2023 in Canada.  The products will be marketed by Stada (as Uzpruvo®) in Europe from late July 2024, by Fuji Pharma in Japan (as Ustekinumab BS (F)) from May 2024, and by JAMP in Canada (as Jamteki®) from Q1 2024. 

Alvotech’s applications for AVT04 elsewhere around the world are pending, including in the US.   

In June 2023, Alvotech and Teva announced a US settlement with J&J relating to ustekinumab, with a market entry date of no later than 21 February 2025.   

On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, biosimilar to Actemra® (tocilizumab).    

This follows the announcement by Celltrion at the end of January 2024, that that it submitted its US BLA for CT-P47. 

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar safety profiles.   

According to the study, QL1207 is the first aflibercept biosimilar developed in China.  

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab).  The study, conducted in 509 patients with moderate to severe plaque psoriasis, demonstrated equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles. 

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial on RT-111, an oral formulation of CT-P43.   

Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE).  Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.  

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional systemic adalimumab HS therapy.  

This comes months after Novartis announced, on 31 October 2023, that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe HS in adults.  

On 12 February 2024, Merck announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or gastroesophageal junction adenocarcinoma with tumours expressing PD-L1 (Combined Positive Score [CPS] ≥ 1).  

In January 2024, Merck announced that the FDA approved KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy for Stage III-IVA cervical cancer.