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Pearce IP BioBlast w/e 16 Feb 2024

by , | Feb 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following:


New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   









In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

16 FEB 2024 | US | New Indication Alert: FDA Approves Genentech’s Xolair® (omalizumab) for Treatment of Food Allergies

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.  CelltrionGlenmark 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. 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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