On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”) as a first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer (NSCLC).  Atezolizumab and cemiplimab (including “quality assured biosimilars”) are listed as therapeutic alternatives to pembrolizumab for metastatic NSCLC.

The WHO Model Lists are updated every two years and are intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists.  Essential medicines are those considered to satisfy the priority health care needs of a population.

Amongst the biopharmaceuticals added to the Model List this year, ustekinumab and adalimumab (with certolizumab pegol, etanercept and infliximab as therapeutic alternatives) were also added to a complementary list (medicines for which specialised monitoring, diagnostics or care are required) for the treatment of adults and children with moderate-to-severe psoriasis.  Emicizumab has been included on the Model List for Haemophilia A.

MSD’s Keytruda® (pembrolizumab) has been approved in multiple jurisdictions for multiple cancer-related indications.  In August 2025, Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  A number of pembrolizumab biosimilars are currently in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

No biosimilars to Roche’s Tecentriq® (atezolizumab) or Regeneron and Sanofi’s Libtayo® (cemiplimab) have been approved to date.

On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®, respectively.  On 1 August 2025, Arrotex announced its strategic licensing agreement with Celltrion for the Australian commercialisation of Celltrion’s ustekinumab and omalizumab biosimilars.

The Arrotex announcement came on the same day that Steqeyma® became the first ustekinumab biosimilar to be PBS-listed (1 August 2025).  Although Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in pre-filled syringe (PFS) presentations in November 2024 and was (together with Steqeyma®) PBS-listed on 1 August 2025.  In August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Omlyclo® in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.

On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

Shanghai Henlius/Organon’s denosumab biosimilars are the fifth pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (launched June 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (launched July 2025), Celltrion’s Stoboclo® and Osenvelt® (launched July 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched).

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

On 1 September 2025, STADA announced that international private equity investment firm, CapVest Partners LLP, has signed a definitive agreement to acquire the majority stake in the company.  The transaction is expected to close in H1 2026, subject to regulatory approvals and other closing conditions.

The majority stake in STADA is currently held by Bain Capital and Cinven, which will each retain a minority stake after the CapVest acquisition.

STADA has a number of strategic biosimilars partnerships, including with Bio-Thera in relation to tocilizumab and golimumab biosimilars in the EU, UK and Switzerland, and with Alvotech in relation to Uzpruvo®, the first European approved and launched biosimilar to J&J/Janssen’s Stelara® (ustekinumab) (January/July 2024), biosimilar denosumab (AVT03, MAA accepted by EMA in October 2024) and Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) launched in Europe in 2022.

In June 2025, STADA’s Afiveg®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), received a positive CHMP opinion for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.  STADA/Xbrane’s Ximluci®, biosimilar to Genentech’s Lucentis® (ranibizumab), was launched in Europe in April 2023.

On 1 September 2025, Searl announced that it has gained approval from Pakistan’s Drug Regulatory Authority to market and sell its denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®.

In July 2023, Searle entered into a licence agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and supply the biosimilars in Pakistan.

Denosumab biosimilars have been approved and launched around the world and, in some countries, are the subject of pending litigation.  For example:

• US: Sandoz (Jubbonti® and Wyost®, launched June 2025), Fresenius Kabi (Conexxence® and Bomyntra®, launched July 2025) and Celltrion (Stoboclo® and Osenvelt®, launched July 2025) all have denosumab biosimilars on the market.  Samsung Bioepis’ Obodence™ and Xbryk™were approved in February 2025.  Amgen has pending US BPCIA litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

• Europe: there are 7 sponsors with denosumab biosimilars approved although none have been launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).

• China: Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia®, was approved in November 2022, followed by Boluojia® (biosimilar to Xgeva®) in May 2024. Mabwell’s Maiweijian™ (biosimilar to Amgen’s Xgeva®) received marketing approval in April 2024.

• Korea: Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.

• Canada: Sandoz launched Jubbonti® and Wyost® in July-August 2024.

• Australia: Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilarsapproved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).  Jubbonti® and Wyost® were PBS-listed and launched in Australia in August 2025.  Amgen commenced patent infringement against Sandoz in Australia in relation to its denosumab biosimilars in June 2025.

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma.  Celltrion submitted its IND to the EMA in November 2024.

In July 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety approved its IND application for its global Phase 3 clinical trial of CT-P44, which followed approval of its US IND submission in December 2024.

In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®, the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar worldwide.

Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15.  In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

On 1 September 2025, Australia’s Pharmaceutical Benefits Scheme published its summary of changes for the month of September.  Among the changes was the PBS-listing of Amgen’s supplemental denosumab brands, Corora® (60mg/ml PFS) and Ganvado® (70mg/ml vial), referencing Prolia® and Xgeva®, respectively.

The additional brands are two of the five Amgen brands of denosumab approved by Australia’s TGA in November 2024 (Ganvado™, Zerount™, Corora™, Rexadev™ and Deptargis™).  In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

The PBS-listing of Amgen’s supplemental denosumab brands comes amidst the commencement of biosimilar competition in Australia.  On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  Jubbonti® and Wyost® were also the first denosumab biosimilars to be approved in Australia (August 2024), followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).

At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.

In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

On 1 September 2025, Medical Dialogues reported that Lupin received approval from India’s Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase 1 study of its certolizumab pegol biosimilar in 200mg PFS presentation, referencing UCB’s Cimzia®.

In July 2025, Lupin Limited and Zentiva Group announced that they entered into a global licence and supply agreement for the commercialisation of Lupin’s certolizumab pegol biosimilar.  Under the agreement, Lupin is responsible for development, manufacturing and supply, with split responsibility for commercialisation: Lupin in the US and Canada, with Zentiva in ROW, predominantly Europe and CIS markets.

Alvotech also has a certolizumab pegol biosimilar in development, AVT10, which it acquired from Xbrane in June 2025.  In early July 2025, Alvotech and Advanz Pharma entered a European supply and commercialisation agreement for AVT10.

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam:

• Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab); and
• Herzuma®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Alongside this launch, Celltrion states that it has secured a one-year supply agreement for Remsima® SC with the largest military hospital in Vietnam and a two-year tender to supply Herzuma® to medical institutions in the central and southern regions of the country.

Celltrion has successfully tendered for the supply of Remsima® and Herzuma® in a number of key regions over the past two years, including Brazil (September 2024), and of Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).

In February 2024, Celltrion secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar).  In June 2024, Celltrion successfully applied to be the exclusive supplier of Remsima®, Herzuma® and Vegzelma® (bevacizumab biosimilar) to France’s largest pharmaceutical procurement group (Union des Hopitaux pour les Achats (UniHA)), until 2027.

Earlier this month, Celltrion’s Remsima® IV formulation was recommended for listing on Australia’s Pharmaceutical Benefits Scheme for reimbursement.  Remsima® IV was approved by Australia’s TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).