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, Samsung Bioepis published the 14^th edition of its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

According to the Report, as of June 2026, the FDA had approved 96 biosimilars across 21 unique biosimilar molecules, 71 of which have been launched.  Since the Q2/2026 report, the biosimilars approved are Lupin’s Ranluspec® (ranibizumab) (referencing Genentech’s Lucentis®), Bio-Thera Solutions/Accord’s Immgolis™ and Immgolis Intri™ (golimumab) (referencing Janssen’s Simponi®/Simponi® Aria), Accord’s Ennumo™ (pegfilgrastim) (referencing Amgen’s Neulasta®) and Sunshine Lake Pharma’s Langlara™ (insulin glargine) (referencing Sanofi’s Lantus®).  The Q2/2026 biosimilar launches in the US were Biocon’s Bosaya® and Aukelso® (denosumab) (referencing Amgen’s Prolia® and Xgeva®).

Samsung Bioepis reports that immunology biosimilars within 5 years of launch (adalimumab, tocilizumab and ustekinumab) show strong growth in the US, with average biosimilar market penetration increasing by 25% year on year.  Notably, ustekinumab biosimilar penetration is increasing at a “significantly faster pace” compared with adalimumab biosimilars, although both are immunology products “mainly covered under the pharmacy benefit”.  As of Q1/2026, ustekinumab biosimilar market share had reached 42%, up 15% on the previous quarter.

FDA-approved ustekinumab biosimilars on the US market are: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Samsung Bioepis’ Pyzchiva® (approved July 2024, launched February 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (approved December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (approved September 2024; launched March 2025), Celltrion’s Steqeyma® (approved December 2024; launched March 2025) and Hikma’s Starjemza™ (approved May 2025; launched November 2025).

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, Medtas announced that it has launched a new in-pharmacy program (myMedtas-Care), following the 1 July 2026 listing of Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab), on the Australian Pharmaceutical Benefits Scheme (PBS).  The in-pharmacy program allows credentialled community pharmacists to administer subcutaneous Wezlana® injections for patients.

Wezlana® is manufactured by Amgen and is the first ustekinumab biosimilar in Australia to be PBS-listed across all product formats of the originator.  It is currently listed in 130 mg and 45 mg vial, and 45 mg and 90 mg pre-filled syringe, presentations.

The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (1 August 2025).  Steqeyma® is not PBS listed in the 45 mg vial presentation.

Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

On 22 July 2026, the Economic Times reported that Intas Pharmaceuticals has received marketing approval from India’s Central Drug Standard Control Organisation (CDSCO) for its trastuzumab emtansine biosimilar, referencing Roche’s Kadcyla®.  No launch plans have been announced to date.

The biosimilar is approved for the same indications as the reference medicine and will be available in 100mg and 160mg single-dose vials for intravenous administration.

The approval was granted based on positive Phase III clinical trial results, which demonstrated the pharmacokinetics, efficacy, safety, and immunogenicity of the biosimilar compared to Roche’s Kadcyla®.  Marketing approval was recommended by the CDSCO, subject to Intas conducting a Phase IV (post-marketing) study in India and submitting the Phase IV clinical trial protocol within three months of the grant of marketing authorisation.

The first reported Kadcyla® biosimilar was Zydus’ Ujvira®, which was launched in India in May 2021.

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.

On 20 July 2026, Samsung Biologics announced that it has entered into an all-cash public tender to acquire 100% of PolyPeptide Group AG, a leading Swiss-based global contract development and manufacturing organisation (CDMO), specialised in peptide-based active pharmaceutical ingredients.

Under the terms of the tender offer, PolyPeptide Group shareholders will receive CHF 44.31 in cash per share.  The transaction is expected to close at the end of 2026, subject to regulatory approvals and closing conditions.

This acquisition will allow Samsung Biologics to leverage PolyPeptide Group’s peptide-based capabilities and expand its current CDMO offerings beyond antibodies and ADCs, addressing growing demand for peptide-based therapeutics, particularly in obesity and diabetes, including GLP-1 therapies.

Following the November 2025 spin-off of biosimilar operations into a new holding entity, Samsung Epis Holdings, Samsung Biologics has focused on its contract development and manufacturing business.