On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.  According to Daiichi, the drug will be available in the US by prescription in approximately two weeks.

This comes less than a month after Japan became the first country globally to approve Datroway® for the same indication, on 27 December 2024.

Daiichi and AstraZeneca are also pursing regulatory approval of Datroway® for the treatment of non-small cell lung cancer (NSCLC) in the US.  On 13 January 2025, the companies announced that the FDA has granted datopotamab deruxtecan Priority Review for patients with previously treated advanced EGFR-mutated NSCLC.

However, as of 24 December 2024, AstraZeneca/Daiichi have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan for the NSCLC indication, based on feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.  According to the companies, they will “continue to work to bring datopotamab deruxtecan to patients with lunch cancer in the EU”.  The European application for datopotamab deruxtecan for breast cancer remains under review.

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise datopotamab deruxtecan (DS-1062) in July 2020.

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 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report.  The report has been released every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

The Q1/2025 edition reports that, as of December 2024, the FDA has approved 64 biosimilars across 17 unique biological molecules, with 41 of those biosimilars having launched in the US market.  In Q4/2024, three new ustekinumab biosimilars were approved in the US (Accord Healthcare/Meiji Seika Pharma’s Imuldosa® (Oct 2024), Biocon’s Yesintek® (Dec 2024) and Celltrion’s SteQeyma® (Dec 2024).

Samsung Bioepis reports that in 2025 the industry is “set to witness the launch of biosimilars in new therapeutic areas and for new molecules such as eculizumab, aflibercept, ustekinumab and denosumab”.

According to the report, on average, biosimilar launches have resulted in 53% market share in biosimilar markets and a 53% reduction in average sales price after 5 years of biosimilar competition.  The fastest uptake of biosimilars has to date occurred in oncology, ophthalmology and pegfilgrastim markets, while biosimilars in immunology, insulin glargine, filgrastim and epoetin alfa markets demonstrate slower uptake.

It is reported that, as of November 2024, the US adalimumab biosimilar market share reached 23% (up 1% since August 2024), with most gains coming from Sandoz’s Hyrimoz® and Organon’s Hadlima®.  The market share for biosimilars which have had a longer time on the market include 86% for trastuzumab and 90% for bevacizumab.

On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s BAT2206 (ustekinumab), biosimilar to Janssen’s Stelara®.

Under the terms of the agreement, Bio-Thera will manufacture BAT2206 in China and World Medicine will be responsible for regulatory approval, importation and commercialisation of the product in Turkey.

Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024.  A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

In December 2024, Bio-Thera announced a partnership with Tabuk Pharmaceuticals to commercialise BAT2206 in Saudi Arabia.  In October 2024, Bio-Thera and Gedeon Richter announced they had entered into an exclusive commercialisation and licence agreement for BAT2206, under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results 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 from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding additional clinical trials.  Based on the results of the NORSE EIGHT trial, Outlook plans to resubmit its Biologics Licence Application (BLA) for ONS-5010 to the US FDA in the first quarter of 2025.

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission 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 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

This closely follows the Canadian approval of both subcutaneous and intravenous formulations of FYB202/Otulfi® on 8 January 2025, for the same indications.

FYB202/Otulfi® was approved in Europe and the US in September 2024.  It is being commercialised in the US, Canada 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.

In March 2024, Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202/Otulfi® in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2025”.  The agreed launch dates for FYB202 in the UK and Canada remain confidential.

On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults.  This follows FDA approval of Omvoh® for ulcerative colitis in October 2023.

In August 2024, Omvoh® was listed for evaluation by Australia’s Therapeutic Goods Administration (TGA) for the treatment of ulcerative colitis.  In December 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an indication expansion of Omvoh® for moderately to severely active Crohn’s disease.

On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH-processing of conventional injected liraglutide (Novo Nordisk’s Saxenda®).

The study is expected to involve 8-10 healthy volunteers and will compare the oral formulation with the conventional injected version.  Lexaria considers this could potentially advance its DehydraTECH-processing technology as a leading drug delivery method.  According to Lexaria, successful outcomes could lead to further clinical trials, potentially impacting the market for GLP-1 drugs significantly and providing new options for patients and healthcare providers.

At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck (known as MSD outside the US and Canada) announced that it is expecting to “file, have approval, and launch [its] subcutaneous pembrolizumab in 2025”.

The announcement follows positive topline results obtained in November 2024 from MSD’s Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).

In October 2024, MSD reported 17% growth in Keytruda® sales for Q3 2024, to US$7.4 billion, attributed to increased global uptake in earlier stage indications, including triple negative breast cancer, renal cell carcinoma and NSCLC, together with continued global demand for metastatic indications.  During 2024, MSD also obtained several Keytruda® approvals in advanced cancers, including cervical cancer (US (January 2024), EU (October 2024)), endometrial carcinoma (US (June 2024), EU (October 2024)) and malignant pleural mesothelioma (US (September 2024)).

On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

This acceptance follows the completion of Eisai’s fast-tracked BLA in October 2024.  Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE.  In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® following safety and efficacy concerns.  The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly Leqembi® IV maintenance dosing in June 2024.