On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4 mL pen) formulation in January 2025.  High concentration Hyrimoz® was first approved in Australia in May 2024 and was recommended by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in its July 2024 meeting.

There are a number of other high-concentration (100mg/mL) adalimumab biosimilars approved in Australia, including Samsung Bioepis’ Hadlima® (February 2023), Cipla/Alvotech’s Ciptunex®/Adalicip® (September 2022) and Celltrion’s Yuflyma® (March 2022).

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for an extended indication of Janssen’s Stelara® (ustekinumab) to children with Crohn’s disease weighing at least 40 kg.  The new indication will apply to Stelara® concentrate for solution for infusion and solution for injection in vial or pre-filled syringe.

Janssen also received positive CHMP opinions for Darzalex® (daratumumab), with the removal of a limitation that adult patients with newly diagnosed multiple myeloma to be treated must be “eligible for autologous stem cell transplant”, and Tremfya® (guselkumab), to include treatment of adults with ulcerative colitis.

AstraZeneca’s Imfinzi® (durvalumab) has received a positive recommendation for the new indication of treating adults with resectable NSCLC at high risk of recurrence.

The CHMP also adopted positive opinions for indication expansions to:

• Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer; and
• Roche’s Columvi® (glofitamab), to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.

In addition, after re-examining its initial opinion at MSD’s request, the CHMP confirmed its positive recommendation for an expanded indication for MSD’s Keytruda® (pembrolizumab) to include patients with unresectable non-epithelioid malignant pleural mesothelioma.  The positive recommendation was initially adopted in November 2024.

On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK.  The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®, used in the treatment of weight management.  Biocon’s products are marketed under the brand names Liraglutide Biocon (gVictoza®) and Biolide (gSaxenda®).

Biocon’s liraglutide became the first UK-approved generic to Novo Nordisk’s liraglutide products in March 2024.

In December 2024, Biocon and its European partner, Zentiva, received approval for liraglutide in the European Union.  The first EU-approved generic liraglutide was Adalvo’s liraglutide pre-filled pen in June 2024.  Teva Pharmaceuticals launched the first authorised generic version of Victoza® in the US in June 2024.

On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic® (linvoseltamab) for treatment of adults with relapsed and refractory multiple myeloma (R/R MM) who have received at least three prior therapies.  Regeneron’s marketing authorisation application for linvoseltamab was accepted by the EMA in February 2024.

Conditional marketing authorisations are granted to medicines which address unmet medical needs.  Less comprehensive clinical data than is normally required may support a conditional marketing authorisation where the benefit of immediate availability of the drug outweighs the risk inherent in the fact that additional data are still required.

The positive recommendation for linvoseltamab was based on data from the “LINKER-MM1” trial, which evaluated linvoseltamab in adults with R/R MM.

Earlier in February 2025, the FDA accepted Regeneron’s resubmitted BLA for linvoseltamab.  The FDA’s target action date is 10 July 2025.

On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.

In late January 2025, the European Commission had asked the CHMP to re-consider the positive opinion granted for Leqembi® in November 2024 following safety information that had since become available.

The CHMP’s reaffirmed recommendation for approval means that the EC will now resume its decision-making process for lecanemab’s marketing authorisation.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease.  However, in the same month, the UK’s NICE determined that the benefits of lecanemab were too small to warrant making the drug available on the NHS.  Similarly, earlier in February 2025, the Scottish Medicines Consortium (SMC) declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.

The resubmission is based on positive results of the NORSE EIGHT clinical trial, announced in January 2025, which are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.  The study was conducted following Outlook’s receipt of a complete response letter (CRL) from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  Additional chemistry, manufacturing and controls (CMC) information requested by the FDA has also been included in the resubmission.

Lytenava™ was approved in the UK for wet AMD in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.  Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.

On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular lymphoma (R/R FL).  The FDA’s PDUFA target action date is 30 July 2025.

Regeneron’s odronextamab BLA for R/R FL or R/R diffuse large B-cell lymphoma (DLBCL) was first accepted by the FDA for priority review in September 2023, with a target action date of 31 March 2024.  In March 2024, the FDA issued complete response letters (CRLs), one for each indication, relating to enrolment status in confirmatory trials evaluating the medicine.  According to Regeneron, the CRLs did not identify any issues regarding efficacy, safety, trial design or manufacturing of odronextamab.

Regeneron’s BLA resubmission for R/R FL was based on achievement of the FDA-mandated enrolment target for the OLYMPIA-1 Phase 3 confirmatory trial of odronextamab in R/R FL.

Odronextamab was approved in Europe in August 2024, as Ordspono™, for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy.

On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and certain paediatric patients.

Switzerland is the fifth jurisdiction to approve Andembry®, and all other approvals have occurred this year.  Australia was first to approve Andembry® in January 2025, closely followed by the UK (January 2025), EU (February 2025) and Japan (February 2025).

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023.  According to CSL, Andembry® is also under review in Canada.

On 25 February 2025, Merck (known as MSD outside the US and Canada), published its 2024 Annual Report, which revealed the company’s expectation that Keytruda® (pembrolizumab) will be selected in 2026 for government price setting under the US Inflation Reduction Act 2022 (IRA).  According to Merck/MSD, such price setting would become effective on 1 January 2028, with US sales of Keytruda® likely declining after that time.

In June 2023, Merck commenced litigation against the US Government in connection with the IRA, alleging, amongst other things, that the “Drug Price Reduction Program” legislated by the Act is unconstitutional.

Novartis has also sued the US Government in relation to the IRA (in September 2023), arguing that the negotiations are “an unprecedented and unconstitutional attempt to compel the nation’s drug manufacturers to sell their products at prices dramatically below their market value”.

On 25 February 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab).  The sBLA is for patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy, with or without cisplatin, and then as a single agent.  The FDA’s target action date is 23 June 2025.

The sBLA is based on results of the Phase 3 KEYNOTE 689 trial.  According to MSD, an interim analysis shows that the results demonstrate significant improvement in event-free survival in the neoadjuvant and adjuvant setting for pembrolizumab in earlier stages of HNSCC.

The FDA review of the sBLA is being conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  Regulatory authorities in Australia, Brazil, Canada, Israel and Switzerland will also be reviewing the application.

Keytruda® is approved as monotherapy and in combination regimens for certain patients with metastatic or unresectable, recurrent HNSCC in countries including the US, Europe, China, Japan, Australia and New Zealand.