Other Updates

On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), seeking all approved reference indications.

The announcement follows Celltrion’s applications for CT-P55 in Canada in May 2026 and Korea in June 2026.  Celltrion is also planning a regulatory filing for CT-P55 in the US.

Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.  In February 2026, Celltrion received approval from the EMA to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.  Celltrion expects this will shorten the overall clinical timeline and reduce development expenses for CT-P55.

Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis).  In June 2026, CSPC Pharmaceutical announced that China’s National Medical Products Administration (NMPA) had accepted a marketing authorisation application for its Secukinumab Injection.

On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting, including positive opinions for one biosimilar and two biopharmaceuticals.

Aurobindo Pharma subsidiary, CuraTeQ Biologics, received a CHMP recommendation for Cavoley™ biosimilar to Amgen’s Neulasta® (pegfilgrastim) as 6 mg solution for injection in a pre-filled syringe.  CuraTeQ has previously had a pegfilgrastim biosimilar approved in the EU under the name Dyrupeg® (March 2025).  Although it has been over 7 years since the approval of the first European pegfilgrastim biosimilar (Accord Healthcare’s Pelgraz®, September 2018), companies continue to pursue pegfilgrastim biosimilars in Europe, with Qilu Pharma obtaining a positive CHMP opinion for Nylaspeg™ (pegfilgrastim) last month.

The CHMP has also recommended marketing authorisation for Roche’s Susvimo® (ranibizumab) as a 100 mg/ml solution for injection.  Susvimo® is delivered via an ocular implant (Contivue™) for continuous release into the vitreous of the eye for the treatment of nAMD.  Susvimo® was approved in the US for nAMD in July 2024 and for DME in February 2025.  The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.

A positive CHMP opinion was also adopted for LIB Therapeutics’ Lyrokaul® (lerodalcibep), a recombinant fusion protein containing a PCSK9 inhibitor, which is indicated for treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet.  The drug was launched in the US (under the name Lerochol®) in May 2026.

At its July 2026 meeting, the CHMP also recommended expanded indications for a number of medicines, including:

• AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for unresectable or metastatic HER2 positive breast cancer (in combination with pertuzumab);
• Amgen’s Repatha® (evolocumab) for adults with established, or at high risk for, atherosclerotic cardiovascular disease; and
• Gilead’s Trodelvy® (sacituzumab govitecan), in combination with pembrolizumab, for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score ≥ 10.

On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD/wet AMD).  Outlook expects Lytenava™ will be available to eligible patients in the US before the end of 2026.

Lytenava™ is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of nAMD.  Outlook Therapeutics considers that Lytenava will have 12 years of Reference Product Exclusivity under the US BPCIA.

Since Outlook’s initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025).  After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process.  In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.  The FDA accepted Outlook’s resubmitted Biologics License Application for Lytenava™ in June 2026 with a Prescription Drug User Fee Act target date of 29 July 2026.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The denosumab biosimilars are the first products of Accord developed and manufactured “end to end” by its parent company, Intas Pharmaceuticals.

Osvyrti® and Jubereq® were approved by the FDA in November 2025.  Intas/Accord settled BPCIA litigation with Amgen in relation to the denosumab biosimilars in July 2025, with the settlement permitting their US launch from 1 October 2025 (subject to regulatory approval).  The US launch of the products comes over 7 months after their European launch in December 2025 (Jubereq® and Osvyrti® having been EU-approved in May 2025).

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.

New Biosimilar Listings

PBAC will consider the following applications for reimbursement of biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) for the first time: Accord Healthcare’s Denolia® and Deskleta® in 60mg/1mL pre-filled syringe (PFS), and Dexeva® and Dostiva® in 120mg/1.7mL PFS (each TGA-approved in October 2025).

Amgen’s Prolia® and Xgeva® are now sponsored in Australia by Arrotex, following a 2024 deal between the companies.  Denosumab biosimilars currently listed on the Pharmaceutical Benefits Scheme (PBS) are Sandoz’s Wyost® and Jubbonti® (PBS-listed 1 August 2025), Amgen’s supplemental denosumab brands Corora® and Ganvado® (PBS-listed 1 September 2025, sponsored by Arrotex) and Celltrion’s Stoboclo® and Osenvelt® (PBS-listed 1 March 2026).

The following biosimilars to Genentech’s Lucentis® (ranibizumab) will also be considered at the November PBAC meeting:

• Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026); and
• Generic Health’s Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).

The only other approved ranibizumab biosimilar in Australia is Samsung Bioepis’ Byooviz® (approved August 2022), which is not currently PBS-listed.

Amended Biosimilar Listings

Amgen has submitted a request for a “broad listing” of Amgevita® (for the higher concentration forms recommended by PBAC at its March 2026 meeting: 20mg/0.2ml & 40mg/0.4ml PFS and 80mg/0.8ml pre-filled pen (PFP)) for the treatment of immune-mediated inflammatory disease.

Originator Biopharmaceuticals

MSD is requesting PBS listing of a new subcutaneous form of Keytruda® (pembrolizumab) (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form.  The TGA approved both strengths of Keytruda SC™ (395mg/2.4mL and 790mg/4.8mL) on 23 July 2026.

Roche has resubmitted its request to list Susvimo® (ranibizumab), a solution for ocular implant (39.5mg/0.395mL), for the treatment of wet AMD.  This follows the PBAC’s decision against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system for the medicine.

Bayer has submitted a request to list high dose Eylea® (aflibercept, 8mg) in 114.3mg/mL intravitreal injection for the treatment of visual impairment due to macular oedema following branch or central retinal vein occlusion (RVO).  Eylea® 8mg has been PBS-listed for nAMD and diabetic macular oedema since 1 November 2024.

Dr Reddy’s Laboratories has submitted a request to list a new indication of Zytorvi® (toripalimab) in 240mg/6mL solution for IV infusion, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC).  Zytorvi® was first listed on the PBS on 1 December 2025 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.

On 21 July 2026, GxP News reported that Biocad has received marketing authorisation from Russia’s Ministry of Health for Nivocad®, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of various cancers.  This is the first biosimilar nivolumab to be approved in Russia.

Nivocad® is approved for the same indications as the reference product.  Nivolumab is included on Russia’s Vital and Essential Drugs list, which allows for increased accessibility for patients.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and NeuClone’s candidate.  Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.

Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide products.

Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Court for the District of New Jersey alleging that Cipla’s generic version of Novo Nordisk’s Ozempic® (semaglutide) infringes four US patents which cover Ozempic® and/or its use: US 8,129,343, US 10,335,462, US 12,295,988 and US 12,569,543.  The complaint arises from Cipla’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to market generic Ozempic® in dosage strengths of 2 mg/3ml, 4 mg/3ml and 8 mg/3ml.

Novo Nordisk had previously commenced litigation in the same Court against Apotex on 10 October 2024 in relation to generic Rybelsus® (semaglutide), on 20 February 2026 in relation to generic Ozempic® tablets® and on 29 April 2026 in relation to generic Wegovy® (semaglutide).  Orders were made by the Court on 12 June 2026 consolidating the three actions.  Apotex received the first US FDA Tentative Approval for its generic Ozempic® ANDA in April 2026, signifying that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.

Novo Nordisk also has patent litigation pending in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan in relation to generic Wegovy®, which was commenced in September 2024.

Meanwhile, on 21 July 2026, Novo Nordisk filed a false advertising lawsuit against Eli Lilly in the US District Court for the District of New Jersey, alleging that Eli Lilly’s nationwide, direct-to-consumer advertising campaigns for GLP-1 medicines are designed to mislead the public about the comparative effects of those medicines for weight loss and type 2 diabetes.

Novo Nordisk claims that Eli Lilly’s ads falsely tell consumers that Zepbound® (tirzepatide) helps patients lose significantly more weight than Novo Nordisk’s Wegovy® and that Eli Lilly’s Mounjaro® (tirzepatide) reduces a key measure of blood sugar control for type 2 diabetes patients significantly more than Novo Nordisk’s Ozempic®.  According to Novo Nordisk, in both cases, the ads are false and misleading because Eli Lilly seeks to support its representations with outdated clinical trials that compare the highest dose of Zepbound®/Mounjaro® to lower doses of Novo Nordisk’s medicines, when there are newer, more effective does of Novo Nordisk’s products available.

Novo Nordisk is seeking preliminary and permanent injunctions preventing Eli Lilly from continuing to disseminate the comparative advertising, as well as damages and corrective advertising.

On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that it may be Epyztek®, biosimilar to J&J’s Stelara® (ustekinumab).

Under the terms of the expanded agreement, Organon will obtain the exclusive Australian commercialisation rights to the biosimilar, while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting.  The drug has not yet been PBS-listed pending lodgement of required documentation.

In October 2025, Samsung Bioepis successfully opposed Janssen’s Australian patent application (AU2019346134) relating to a method of treating ulcerative colitis (UC) with Stelara® (ustekinumab).

This followed a decision of the Federal Court of Australia in June 2025, ordering that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042), which related to methods of treating UC with ustekinumab.

Organon is currently sponsoring three of Samsung Bioepis’ biosimilars in Australia under the existing agreement: Brenzys® (etanercept), which was TGA-approved July 2016 and PBS-listed July April 2017; Renflexis® (infliximab), TGA-approved November 2016 and PBS-listed August 2017; and Hadlima® (adalimumab), TGA-approved in January 2018, launched March 2021 and PBS-listed in April 2021.

In June 2026, the companies announced the expansion of their Canadian collaboration, first established in 2013, from five to six biosimilars to include Pyzchiva®, biosimilar to J&J’s Stelara (ustekinumab).

On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab).

Henlius received approval from China’s National Medical Products Administration for the investigational new drug (IND) application for HLX18 in March 2026.  This followed FDA approval of the HLX18 IND application in December 2025.

The Phase 1 study, initiated in June 2026, is designed to evaluate the similarity in pharmacokinetic profile, efficacy, safety and immunogenicity of HLX18 and BMS’ Opdivo® in patients with resected oesophageal or gastroesophageal junction cancer, melanoma or urothelial carcinoma.  Primary completion of the study is expected in August 2027.

Nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In June 2026, Orion Pharma announced it entered into an agreement with Shilpa Biologicals for the European commercialisation of Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The launch is expected to occur in the coming days.

The semaglutide injection was approved as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) for once-weekly treatment of adult patients as an adjunct to diet and exercise.  This is the second market to date, following India, where Sun Pharma’s generic semaglutide has received approval.

On 18 July 2026, Business Insider Africa announced that Novo Nordisk is partnering with Swiss pharmaceutical company, Acino, to launch Extensior™, a lower-cost version of Ozempic® (semaglutide) on 27 July 2026 in South Africa.  Extensior™ will be available in 0.25mg, 0.5mg and 1mg doses in the same injection device as Ozempic®.  This followed Novo Nordisk securing an interim order from the Gauteng High Court preventing iDexis from manufacturing and selling compounded semaglutide medicines in South Africa in June 2026.  iDexis has appealed the court order and decisions made by SAHPRA and the South African Pharmacy Council.

A number of generic semaglutide products have already launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

Novo Nordisk has recently launched alternative semaglutide formulations globally.  Novo Nordisk’s Wegovy® pill was the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU.  Marketing authorisation for the Wegovy® pill and Wegovy® 7.2mg injection in a single-dose pen was granted by the European Commission on 15 July 2026.  This followed the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.