Other Updates

The Australian Government has reached an agreement with Sanofi and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to ensure Dupixent® (dupilumab) remains listed on the Pharmaceuticals Benefits Scheme (PBS) for eczema treatment, as it has been since 2021.  In July 2024, higher than expected prescription numbers had risked Dupixent® being withdrawn from the PBS.  Eczema Support Australia lobbied in support of the continued listing and has welcomed the decision.

Dupixent® will be considered in March 2025 for PBS listing for severe atopic dermatitis and uncontrolled severe asthma.

On 13 December 2024, Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) pre-filled syringe (PFS) (6mg) for treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO).

Vabysmo® was first approved in the US in January 2022 in a vial format and is available in multiple countries, including Europe, Canada and Australia.  Vabysmo® PFS for nAMD, DME and RVO was approved by the US FDA in July 2024.

On 12 December 2024, Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial.  The FLOW trial assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events.

The EMA will therefore allow Novo Nordisk to add risk reduction for events related to kidney disease to the label of its diabetes drug Ozempic®.

On 14 May 2024, we reported that Cipla had commenced Federal Court proceedings challenging the patent term extension (PTE) to Novo Nordisk’s liraglutide formulation patent (AU2004290862).  Liraglutide is marketed by Novo Nordisk in Australia as Victoza®.  Cipla argued that the PTE was invalid on the basis that only patents for active ingredients and not patents for formulations (which included mixtures of active ingredient(s) and excipients) were eligible to be extended under the Australian PTE regime.

On 12 December 2024, the Federal Court delivered a decision rejecting Cipla’s challenge and upholding Novo Nordisk’s PTE, which extends the patent term from 18 November 2024 to 26 August 2025.

Accordingly, subject to any appeal, formulation patents continue to be eligible for PTEs in Australia.  Cipla can also no longer achieve its intended Australian liraglutide product launch date of January 2025, as the Federal Court upheld Novo Nordisk’s cross-claim seeking injunctive relief on the basis that it was not in dispute that Cipla’s product would infringe Novo Nordisk’s patent.

At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab) for prevention of recurrent attacks of hereditary angioedema (HAE).  Galderma’s Nemluvio® (nemolizumab), for treatment of atopic dermatitis and prurigo nodularis, and AstraZeneca’s Kavigale® (sipavibart), for prevention of COVID-19 in immunocompromised people aged 12 years and older, also received positive opinions.

Indication expansions were recommended for seven medicines including Amgen’s Blincyto® (blinatumomab) as monotherapy (as part of consolidation therapy) for newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL; GSK’s Jemperli® (dostarlimab) for first line treatment (with chemotherapy) of all primary advanced or recurrent endometrial cancer who are candidates for systemic therapy; and Eli Lilly’s Omvoh® (mirikizumab) for moderately to severely active Crohn’s disease.

Six biosimilars received positive opinions at CHMP’s December meeting as reported here.

On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.

Pursuant to an exclusive licence agreement entered in December 2021, Hikma is responsible for FDA registration of RGB-14 and has exclusive rights to commercialise it in the US following approval.  Gideon Richter is responsible for development.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar (FKS518) was accepted in May 2024, Teva’s BLA for TVB-009P (denosumab) was accepted in October 2024 and Organon/Shanghai Henlius’ BLA for HLX14 (denosumab) was accepted in late October 2024.  Celltrion filed an aBLA for CT-P41, biosimilar denosumab, in December 2023, which received a positive CHMP opinion on 12 December 2024.

At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.

Four of these are Celltrion biosimilars: Eydenzelt®/CT-P42 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®; Osenvelt®/CT-P41 (denosumab), biosimilar to Amgen’s Xgeva®; Stoboclo®/CT-P41 (denosumab), biosimilar to Amgen’s Prolia®; and Avtozma®/CT-P47 (tocilizumab), biosimilar to Roche’s Actemra®.

Biocon’s Yesintek® (ustekinumab), biosimilar to J&J’s Stelara® and CuraTeQ’s Zefylti® (filgrastim), biosimilar to Amgen’s Neupogen® were also given the green light by CHMP at its December 2024 meeting.

Eydenzelt® follows three aflibercept biosimilars already approved in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024) and Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024).  Formycon/Klinge’s FYB203/Baiama®/Ahzantive® received a CHMP positive opinion in November 2024.  Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024.  The EMA has accepted MAAs for denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius Biotech/Organon (HLX14, May 2024).  In November 2024, CHMP adopted positive opinions for Samsung Bioepis’ Obodence™ and Xbryk™ (SB16).

The first tocilizumab biosimilar launched in Europe was Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023.  This was followed by the EU-approval of Biogen’s IV tocilizumab, Tofidence™, in June 2024.

Three ustekinumab biosimilars were launched during 2024, STADA/Alvotech’s Uzprovo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

On 9 December 2024, GSK announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a treatment for relapsed or refractory multiple myeloma (RRMM).

This follows the NMPA granting Breakthrough Therapy Designation for the same application in September 2024.  In the same month, GSK also announced that Blenrep® in combination with BorDex or PomDex (pomalidomide plus dexamethasone) for RRMM was accepted in Japan.

Also on 9 December 2024, GSK announced results from a planned interim analysis of the DREAMM-7 trial evaluating Blenrep® in combination with BorDex, versus daratumumab in combination with BorDex, as a second line or later treatment for RRMM.  The results showed significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse among patients receiving the Blenrep® combination versus the daratumumab comparator.

On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), in the Middle East and North Africa (MENA).

Under the agreement, MS Pharma will have rights to license, commercialise and manufacture FYB202 in Saudi Arabia for countries of the MENA region.  According to MS Pharma, it plans to submit an application for regulatory approval of FYB202 in MENA countries “at the earliest opportunity”.

FYB202 (Otulfi®) was approved in Europe and the US in September 2024.  It is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

On 9 December 2024, MSD (known as Merck in the US and Canada) announced that its Phase 3 KEYLYNK-0001 trial for Keytruda® (pembrolizumab) plus chemotherapy, followed by maintenance with AstraZeneca’s Lynparza® (olaparib) (with or without bevacizumab) met its primary endpoint of progression-free survival in first line treatment of BRCA non-mutated advanced epithelial ovarian cancer.  The secondary endpoint of overall survival was not met.

MSD intends to present the results at upcoming medical meetings and to discuss them with regulatory authorities.

These results follow positive results for MSD’s Phase 3 trial evaluating subcutaneous administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy, in adults with metastatic NSCLC.