On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.   

For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments. 

Four biosimilars will be considered for new listings: 

• Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis 

• Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis 

• Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria 

• Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease 

One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). 

Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following: 

On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.  The submission was made under the Accelerated Approval pathway.  The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. 

Opdivo® is was approved in Europe in August 2023 for treatment of melanoma as monotherapy. 

Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York alleging that Sanofi is in breach of its commercialisation agreement.  The issues relate to contracts Sanofi negotiates with intermediaries between drug-makers, pharmacies, and insurance companies.  Regeneron alleges that Sanofi has not allowed it access to the relevant contracts to verify compliance with its profit-sharing arrangement. 

Regeneron and Sanofi have previously been on the same side in dupilumab patent proceedings against Amgen and Immunex.  In that matter, the PTAB denied the institution of a review, deciding that the petitioners had not established a reasonable likelihood that they would prevail in showing the unpatentability of the patent. 

On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.  The FDA’s target action date is 18 April 2025.

Regeneron and Sanofi had received a Complete Response Letter from the FDA in October 2023 requiring further efficacy data for the use of Dupixent® for CSU.

The resubmitted sBLA was supported by data from the LIBERTY-CUPID Phase 3 clinical program.  This included a confirmatory phase 3 study of Dupixent® which met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.

Japan was the first country in the world to approve Dupixent® for CSU in February 2024.

In October 2024, Sanofi reported that sales of Dupixent® for Q3 2024 had increased globally by 24% to €3.5 billion and were expected to total about €13bn for the full year.

On 6 November 2024, Regeneron and Sanofi announced that the EC, as recommended by CHMP, has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy.

This expands the initial approval in the EU for EoE in adults and adolescents and makes Dupixent® the first medicine indicated to treat these young patients.  Dupixent® is also approved in this age group in the US and Canada.

On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies.  Sanofi reports that sales of Dupixent® for the quarter have increased globally by 24% to €3.5 billion and are expected to total about €13bn for the full year.

Sanofi’s biopharma highlights for Q3 are reported to include its September 2024 new indication approvals for Dupixent® (COPD in the US and China and CRSwNP adolescents in the US) and for Sarclisa® (isatuximab) (newly diagnosed multiple myeloma (NDMM) in the US).

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 treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.  In the same month, Sanofi reported that Q2 2024 Dupixent® sales grew by 29.2% to over €3.3B.

At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication extensions for five.

The new biologics are AbbVie’s antibody drug conjugate Elahere® (mirvetusimab soravtansine) for treatment of adults with ovarian, fallopian tube or primary peritoneal cancer (which received FDA approval in March 2024); Pfizer’s Hympavzi® (marstacimab) for bleeding episodes in patients aged 12 years and older with sever haemophilia A or B; and Henlius/Intas’ Hetronifly® (serplulimab) for first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC).

Hetronifly® (serplulimab) will reportedly be commercialised by Intas through its subsidiary, Accord Healthcare, across more than 30 countries in Europe.  Serplulimab has previously been launched as HANSIZHUANG in China, Indonesia, Cambodia and Thailand.

The five recommended indication expansions for biologics are:

• Janssen’s Darzalex® (daratumumab), in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant;
• Sanofi’s Dupixent® (dupilumab) for eosinophilic esophagitis in adults, adolescents and children aged 1 year and older who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy;
• AstraZeneca’s Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis;
• Novo Nordisk’s Esperoct® (turoctocog alfa pegol) for treatment and prophylaxis of bleeding in all age groups with haemophilia A (congenital factor VIII deficiency); and
• MSD’s Keytruda® (pembrolizumab) for two cancer indications: (i) in combination with carboplatin and paclitaxel, followed by Keytruda® as a single agent, for first-line treatment of adults with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy; and (ii) in combination with chemoradiotherapy (CRT) for FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.

In addition, two aflibercept biosimilars received positive opinions at CHMP’s September 2024 meeting, as reported here.

On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).  This follows the FDA’s May 2024 acceptance of the sBLA for Dupixent® for priority review for adolescents with CRSwNP.

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent® grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024.

On 12 September 2024, PM Live reported that Sanofi and Regeneron’s Dupixent® (dupilumab) has been approved by the UK Medicines Healthcare products Regulatory Agency (MHRA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).

This follows an announcement by the companies the previous day that a confirmatory phase 3 study of Dupixent® met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.  In the same month, Sanofi reported that Q2 2024 Dupixent® sales grew by 29.2% to over €3.3B.