On 3 December 2025, Celltrion announced that it received FDA approval for a new 300 mg/2 mL pre-filled syringe presentation of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  The US approval follows EU approval of the same dosage form in November 2025.

Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status.  It has also been approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), 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.  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.

On 27 November 2025, Celltrion announced that it has launched Omlyclo®, the first biosimilar to Novartis’ Xolair® (omalizumab) in Brazil, Latin America’s largest pharmaceutical market.

Two days earlier, on 25 November 2025, Celltrion also announced the completion of its Omlyclo® launch in major European countries including Germany, Spain, the UK and France, and that it has successfully secured bids from multiple hospital groups in the Netherlands, securing 70% of the Dutch market.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.  Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand  (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly 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.

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

• 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; and
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025.  In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025.  The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, 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 the current status of the application is recorded as “inactive”.

On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  According to Celltrion, the additional strength of Omlyclo® “can significantly decrease the frequency of injections and reduce injection burden and discomfort without compromising efficacy and safety”.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.

Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).

Omalizumab biosimilars are also under development by Alvotech/Kashiv, Aurobindo, Teva and Glenmark.  In October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for its omalizumab biosimilar, AVT23.

On 6 October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

AVT23 (also known as ADL-018) was developed by Alvotech in collaboration with Kashiv Biosciences and is the subject of an October 2023 licensing agreement under which Advanz Pharma has exclusive commercialisation rights for the European Economic Area (European Union, Norway, Iceland and Lichtenstein), the UK, Switzerland, Canada, Australia and New Zealand.  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Celltrion has already commenced the European launch of its omalizumab biosimilar, Omlyclo®, beginning in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of patent infringement actions in at least the UK and Europe.  Omalizumab biosimilars are also under development by Aurobindo, Teva and Glenmark.

On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.

ADL-018 was developed by Kashiv Biosciences, 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.

Kashiv commenced Phase III trials of ADL-018 in October 2023 (patient enrolment completed in July 2024) in patients with chronic idiopathic/spontaneous urticaria following completion of Phase I trials in June 2023.

On 19 September 2025, Celltrion announced that it will begin the European launch of its biosimilar omalizumab, Omlyclo®, in Norway.  Omalizumab biosimilars are also being developed by Aurobindo, Teva and Glenmark.

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway.  The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.

On the same date, Celltrion also announced results from its global Phase 3 clinical trial of Omlyclo®, involving 619 patients with chronic spontaneous urticaria.  Starting from week 12, patients who received Omlyclo® were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomised in a 1:1 ratio to either switch to Omlyclo® or to continue receiving the reference product.  The results demonstrated comparable efficacy and safety to the reference product.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly 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.

On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, to bring ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), to the Latin American market.

Under the agreement, Kashiv will handle product development, while CRISTÁLIA is responsible for licensing, distribution, and commercialisation across Latin America.  According to IQVIA records, omalizumab generated around $5 billion in global sales in 2024, with approximately $140 million from Latin America, highlighting the region’s growing role in the biologics 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.

Omalizumab biosimilars are also under development by Celltrion, Aurobindo, Teva and Glenmark.  On 10 September 2025, Celltrion confirmed that Omlyclo®/CT-P39 (omalizumab) is set to be launched in Europe later in 2025, securing ‘first mover advantage’.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject patent infringement actions in at least the UK and Europe.

On 10 September 2025, Celltrion confirmed that it is planning the European launch of Omlyclo® (CT-P39), biosimilar to Genentech’s Xolair® (omalizumab), later this year to secure ‘first mover’ advantage.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.  On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s biosimilar omalizumab, ADL-018, for the Middle East and North Africa (MENA).  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with 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.

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).