On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.

Celltrion announced the Korean approval of the autoinjector presentation of Omlyclo®, biosimilar to Novartis’ Xolair®, in December 2025.  The launch comes three months after Celltrion’s Korean launch of its high dose (300 mg) Omlyclo® formulation.

Celltrion’s Omlyclo® (CT-P39) is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, while in January 2026, high dose Omlyclo® (PFS and autoinjector) was approved in Canada.

Kashiv BioSciences/Alvotech are likely to be the next companies with an approved omalizumab biosimilar on the market.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.

The Canadian filing follows a series of regulatory advances for ADL-018.  Marketing applications for ADL-018 were accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March 2025 and by the European Medicines Agency (EMA) in October 2025.

Beyond Canada, Kashiv has agreements for the commercialisation of ADL-018 with Brazilian pharmaceutical company, CRISTÁLIA, for the Latin American market (11 August 2025) and MS Pharma for MENA markets (August 2025).

The only omalizumab biosimilar currently approved in Canada, and anywhere else in the world, is Celltrion’s Omlyclo®.  Omlyclo® was approved in Canada in 75mg and 150mg formulations in December 2024 and in 300mg PFS and autoinjector presentations in January 2026.

Omlyclo® has also been approved in: the EU (May 2024 and November 2025 (300mg)); Korea (June 2024 (PFS), December 2025 (autoinjector), 300mg formulation launched 30 March 2026)); Australia (November 2024); the US (March 2025 (75 mg/0.5ml and 150 mg/ml PFS) and December 2025 (300mg)); New Zealand (April 2025); and Japan (March 2026).  Celltrion commenced its European rollout of Omlyclo® in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US Patent No. 12,030,959.  The patent relates to methods for treating food allergies in paediatric patients by administering omalizumab.

Amneal and Kashiv argue that the claims of the US959 patent are invalid because they lack novelty and/or are obvious, including in light of articles disclosing the results of phase 1 or 2 clinical trials of omalizumab in patients with food allergies.

Amneal submitted a Biologics Licence Application (BLA) to the FDA for its omalizumab (ADL-018), biosimilar to Genentech/Novartis’ Xolair®, in September 2025.  ADL-018 was developed by Kashiv, with Amneal holding exclusive US commercialisation rights for the product, under a July 2024 licensing agreement.

Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025  (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are in development, including by Teva (acceptance of regulatory applications for review by the FDA and EMA announced March 2026) and CuraTeQ (phase 3 biosimilar omalizumab trial completed April 2026).

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP;
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
• Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.

Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively.  Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml).  There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025.  The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.

Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting.  However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting.  PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.

Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive marketing approval in Australia.

Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  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.

During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027.  This includes:

• biosimilars that are already on the market: Alymsys® (bevacizumab) (FDA-approved April 2022, referencing Avastin®), Releuko® (filgrastim) (FDA-approved March 2022, referencing Neupogen®), Fylnetra® (pegfilgrastim) (FDA-approved May 2022, referencing Amgen’s Neulasta®); and
• those which are yet to launch: Boncresa™ and Ozilutus™ (denosumab) (FDA-approved December 2025 in partnership with mAbxience, referencing Amgen’s Prolia® and Xgeva®) and omalizumab biosimilar, ADL018 (FDA approval pending, under licence with Alvotech, referencing Genentech/Novartis’ Xolair®).

Amneal is also expecting approvals for 6+ advanced pipeline biosimilar products in 2028-2030, including abatacept (referencing BMS’ Orencia®) certolizumab (UCB’s Cimzia®), pembrolizumab (MSD’s Keytruda®), nivolumab (BMS’ Opdivo®) and dulaglutide (Eli Lilly’s Trulicity®).

In 2030+, Amneal is planning for 10+ pipeline products to be approved, including biosimilars of dupilumab (referencing Regeneron/Sanofi’s Dupixent®), risankizumab (referencing AbbVie’s Skyrizi®) and guselkumab (referencing Janssen’s Tremfya®).

Amneal presently intends to commercialise the biosimilars itself in the US and India, with a partnership model being employed in the rest of the world.

On 6 April 2026, Aurobindo’s wholly owned subsidiary, CuraTeQ Biologics, announced it has obtained positive top-line results from a Phase 3 study of BP11 (omalizumab, 300 mg), biosimilar to Genentech/Novartis’ Xolair®.

According to CuraTeQ, the study, which was conducted in 608 patients across 80 sites in Europe and India, successfully met all primary endpoints, demonstrating comparable efficacy and safety to Xolair® in patients with chronic spontaneous urticaria at the 300 mg dose.

Buoyed by these results, which follow completion of a Phase 1 study in March 2024, CuraTeQ is planning to complete regulatory filings with both the European Medicines Agency and the FDA by the end of Q2 2026.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® has been approved in: the EU (May 2024, with a high dose (300 mg) form approved November 2025); Korea (June 2024, as PFS, with autoinjector approved December 2025; high dose formulation launched 30 March 2026); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150 mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose); New Zealand (April 2025); and Japan (March 2026).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Biosimilar omalizumab is also under development.  Teva announced in March 2026 that its regulatory applications for an omalizumab biosimilar have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications.  On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.

The Korean launch follows the January 2026 Canadian approval of high dose Omlyclo® (PFS and autoinjector) and approvals of a PFS presentation of the 300 mg dosage form in the US in December 2025 and EU in November 2025.

Celltrion is actively marketing Omlyclo® around the world, with a “launch event” held in Brazil on 31 March 2026, at which Celltrion and “key opinion leaders” presented clinical data, global prescribing experience and “value for use in clinical settings” in relation to the biosimilar.  Omlyclo® was launched in Brazil in November 2025 and secured a state government tender in Santa Catarina.

While Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world, at least Aurobindo, Teva, Glenmark and Kashiv  have omalizumab biosimilars under development.  On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab).  At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications.

Ponlimsi® was approved in the EU in November 2025, together with Teva’s biosimilar to Amgen’s Xgeva® (denosumab), Degevma®.  The US has a highly competitive denosumab biosimilar market with a number of denosumab biosimilars already launched, including Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), 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), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026).

Teva’s omalizumab biosimilars are behind Celltrion’s Omlyclo® (omalizumab), which has already been approved in the EU (May 2024; high dose (300mg) form approved November 2025) and the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  Aurobindo, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.

On 27 March 2026, Celltrion announced that Japan’s Ministry of Health, Labour and Welfare has approved two of its biosimilars: Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg.

According to Celltrion, Omlyclo® is the first omalizumab biosimilar approved in Japan with the full range of on‑label indications, namely bronchial asthma, idiopathic chronic urticaria, and seasonal allergic rhinitis.  The product will be offered in both prefilled syringe (PFS) and autoinjector (AI) presentation.

Omlyclo® was the first omalizumab biosimilar approved in: the EU (May 2024); Korea (June 2024, as PFS, with autoinjector approved December 2025); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status); and New Zealand (April 2025).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, Latin America’s largest pharmaceutical market.  Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development

A number of aflibercept biosimilars are approved in Japan including Alvotech/Fuji Pharma’s AVT06 (September 2025) and Sam Chun Dang’s SCD411 (September 2025).  Under a settlement and licence agreement with Regeneron & Bayer announced in January 2026, Alvotech was permitted to launch AVT06 in Japan from 1 January 2026.

On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg pre-filled syringe (PFS) and autoinjector (AI) formulations.  Celltrion now has Canadian approved PFS and AI formulations of Omlyclo® in all strengths of Canadian approved Xolair® (75mg, 150mg and 300mg).

Omlyclo® was the first omalizumab biosimilar approved in Canada in December 2024 and remains the only Canadian approved biosimilar omalizumab to date.

The approval of the high dose formulations of Omlyclo® in Canada follows approvals of a PFS presentation of the 300mg dosage form in the US, in December 2025, and in the EU, in November 2025.

Aurobindo, Teva, Glenmark and Kashiv  also have omalizumab biosimilars under development.   On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.