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).

On 5 August 2025, Kashiv BioSciences and MS Pharma announced that they entered into a licence and supply agreement for Kashiv’s ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), for the Middle East and North Africa (MENA).

Under the terms of the agreement, Kashiv is responsible for the development of the biosimilar and MS Pharma is responsible for licensing, distribution, and commercialisation in the MENA region.  The agreement also provides an option for MS Pharma to manufacture the biosimilar in Saudi Arabia.  MS Pharma is expected to submit an application for regulatory approval of ADL-018 in MENA countries in Q4 2025.

In October 2023, Kashiv entered into an exclusive licensing agreement with Alvotech in relation to the commercialisation of Kashiv’s omalizumab biosimilar in the EU, UK, Australia, Canada and New Zealand.  Alvotech and Advanz Pharma subsequently entered into an agreement in relation to the commercialisation of omalizumab (AVT23) in those countries.  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, and was first approved in pre-filled syringe (PFS) presentations in November 2024, which were listed on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2025.

Omlyclo® is also approved in the EU (May 2024), Korea (June 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of legal disputes in at least the UK and Europe.

Kashiv Biosciences/Alvotech had a marketing application for omalizumab biosimilar AVT32 accepted in the UK in March 2025, while other companies, including Aurobindo, Teva and Glenmark, reportedly have omalizumab biosimilars under development.

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:

• Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
• Celltrion’s Steqeyma®, the first biosimilar to Janssen’s Stelara® (ustekinumab) to be PBS listed; and
• Celltrion’s Omlyclo®, the first biosimilar to Genentech/Novartis’ Xolair® (omalizumab) to be PBS listed.

Each of these biosimilars is PBS listed for all reference indications.

On the same day, Arrotex Pharmaceuticals announced that it has entered into a strategic licensing agreement with Celltrion to commercialise the Celltrion ustekinumab and omalizumab biosimilars in Australia.

Celltrion’s Omlyclo® is the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting.  Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.

Sandoz’s Wyost® and Jubbonti® and Celltrion’s Steqeyma® were recommended for listing in Australia at the November 2024 PBAC meeting.

Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing at the March 2024 PBAC meeting, but Amgen is not proceeding with the PBS-listing and the PBAC process has ceased.  Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was recommended for PBS-listing at PBAC’s March 2025 meeting.  However, the current status of the PBS application indicates that it is inactive as Samsung Bioepis has not advised whether it intends to proceed or not within 60 days of receiving the ratified PBAC minutes.

At the November 2025 meeting, PBAC will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt® for PBS-listing for all reference indications.

Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.

In its previous quarterly earnings call in April 2025, Roche had said that it did not expect competition to Perjeta® until late 2027.  The biosimilar expected to provide the first serious competition remains Henlius/Organon’s HLX11, which is being considered for approval in Europe, the US, and China.  Organon’s own earnings call is scheduled for 5 August 2025.  Other pertuzumab biosimilars have been approved in India (Zydus and Intas) and Russia (Biocad).

Celltrion’s Omlyclo® (omalizumab) is already 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 legal disputes in at least the UK and Europe.