On 26 June 2025, New Zealand Doctor reported that Novo Nordisk is set to launch Wegovy® (semaglutide) in New Zealand from 1 July 2025.

New Zealand’s Medsafe approved Wegovy® in March 2025 for two indications:

• an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults and adolescents aged 12 years and above; and
• as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) without established Type 1 or Type 2 diabetes.

Semaglutide was first approved in New Zealand as Ozempic® in March 2023, indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Wegovy® was launched in Australia in August 2024, following its approval in September 2022 for weight management.  In December 2024, Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® to reduce the risk of MACE in overweight and obese adults with established CVD and without established Type 1 or Type 2 diabetes.

Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Custom Compounding, a Texas based compounding pharmacy.

The Complaint, lodged on 24 February 2025, alleges that the FDA’s decision was arbitrary and reckless and is contrary to law.

In removing semaglutide from the Drug Shortages List, the FDA confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Novo Nordisk has argued that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology.  Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns.  This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.

On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list.  The FDA has confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Semaglutide injection products, namely Novo Nordisk’s popular weight-loss drug Wegovy® and its diabetes drug Ozempic®, were first added to the FDA’s drug shortages list in March 2022 and August 2022, respectively.  While it was announced in October 2024 that all doses of Wegovy® and Ozempic® were available in the US, the FDA has continued to monitor the availability of the drugs.  Based on information provided by Novo Nordisk, the FDA has now concluded that Novo Nordisk’s supply of semaglutide is currently meeting or exceeding demand and it has sufficient reserves to meet or exceed projected demand.

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults with established cardiovascular disease (CVD) and without established Type 1 or Type 2 diabetes.  The indication extension was registered by the TGA on 19 December 2024.

Novo Nordisk obtained US approval for the same indication of Wegovy® in March 2024.  In July 2024, the CHMP adopted a positive opinion for an update to the label for Wegovy® in Europe to reflect a risk reduction of MACE in adults with established CVD and either overweight or obesity without diabetes.

On 5 February 2025, Novo Nordisk released its financial results for 2024, reporting a 26% sales increase (at constant exchange rates (CER)) to DKK 128.3 billion.  Sales in Novo Nordisk’s diabetes care segment (including Ozempic® (semaglutide), Rybelsus® (oral semaglutide) and Victoza® (liraglutide)) increased by 20% (CER) with its global diabetes value market share at 33.7% (constant over the last year).  Meanwhile, Novo Nordisk’s obesity care product sales (Wegovy® (semaglutide) and Saxenda® (liraglutide)) grew by 57% at CER to DKK 65,146 million, with its volume market share being 70.4%.

Recent highlights are reported to include the approval of Awiqli® (insulin icodec) in Europe (May 2024), Japan (June 2024) and China (June 2024); US approval (January 2025) and positive EU opinion (December 2024) for an update of the Ozempic® label based on the FLOW kidney trial; submission of the SOUL cardiovascular outcomes trial and STRIDE functional outcomes trial (oral semaglutide) in the US and EU; US approval (March 2024) of Wegovy® to reduce the risk of major cardiovascular events and positive EU opinion (July 2024) to reflect a risk reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either overweight or obesity without diabetes; and a positive EU opinion for a Wegovy® label expansion for obesity-related HFpEF (November 2024).

Novo Nordisk predicts sales growth of 16-24% at CER for 2025.  This is expected to be driven mainly by volume growth of GLP-1 based treatments for obesity and diabetes care, but also takes into account competition and continued pricing pressure within those markets.

On 28 January 2025, Novo Nordisk announced that the US FDA has approved an indication expansion for Ozempic® (semaglutide) to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.

This follows the positive recommendation for PBS listing of Ozempic® for type 2 diabetes mellitus by Australia’s PBAC in December 2024.  Earlier the same month, the EMA’s CHMP had adopted a positive opinion for an update of the Ozempic® label to reflect data from the FLOW kidney outcomes trial which assessed the risk reduction from Ozempic® therapy in chronic kidney disease-related events.

In September 2024, Australia’s TGA accepted Novo Nordisk’s application for Ozempic® for reducing the risk of kidney failure.

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly.  The results reportedly demonstrate a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo, with patients treated with the high dose semaglutide achieving weight loss of 20.7% compared to a reduction of 17.5% with semaglutide 2.4 mg and a reduction of 2.4% with placebo.

Novo Nordisk expects results from a second high dose semaglutide Phase 3 trial (STEP UP T2D) in adults with type 2 diabetes and obesity within the next few months.

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases
• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis.

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s Imfinzi® for use in combination with platinum-based chemotherapy for the treatment of deficient mismatch repair (dMMR) endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer.

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations.

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma.

The PBAC reports that some earlier recommendations have been extended:

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis and uncontrolled severe asthma

Additionally, two recommendations have been rescinded:

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis
• AbbVie’s Skyrizi® (risankizumab) for Crohn’s disease

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®.

In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns.

In a response made available on 26 November 2024, the US Alliance for Pharmacy Compounding (APC) has provided a lengthy rebuttal to Novo Nordisk’s assertions arguing that synthetic semaglutide APIs are safe and rigorously regulated, often showing comparable or better impurity profiles than Novo Nordisk’s recombinant APIs.

The association highlights that compounded semaglutide has been successfully dispensed in large quantities during the ongoing shortage, meeting patient needs without safety concerns.  The APC challenges Novo Nordisk’s attempt to list semaglutide on the FDA’s DDC list, arguing it would unjustly restrict patient access.