Celltrion Launches 300 mg (High Dose) Biosimilar Omalizumab in Europe

Aug 25, 2026

On 25 August 2026, Celltrion announced that it has launched Omlyclo® 300 mg, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in Europe, commencing in Germany, the UK and France.

Omlyclo® was the first (and remains the only) omalizumab biosimilar to be approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation following in November 2025. Celltrion commenced its European rollout of Omlyclo® (75 mg/0.5 mL and 150 mg/1 mL) in Norway in September 2025, and completed the launch of those formulations in major European countries including Germany, Spain, the UK and France in November 2025.

The 300 mg formulation of Omlyclo® has also been launched in Korea (30 March 2026) and approved in a number of countries including the US (December 2025) and Canada (January 2026).

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025. Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand. Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.

Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

Celltrion Files Second Korean Application for Biosimilar to MSD’s Keytruda® (Pembrolizumab)

Aug 24, 2026

On 24 August 2026, Celltrion announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab). This is the second biosimilar pembrolizumab application filed in Korea, following Samsung Bioepis’ application earlier this month for SB27.

Commencing with its Korean application, Celltrion plans to “sequentially pursue applications for CT-P51 in major global markets”, including the US, EU and Canada. According to Celltrion, it has a competitive advantage in relation to biosimilar pembrolizumab due to its large-scale in-house production facilities and its strong direct sales distribution network.

Celltrion’s Korean application regarding CT-P51 is based on clinical trial results in 228 patients with melanoma. In July 2026, Celltrion terminated its Phase 3 trial of CT-P51 in Europe in order to streamline its pembrolizumab development program. It also recently streamlined its US Phase 3 trial for CT-P51 in patients with untreated metastatic non-squamous non-small cell lung cancer by reducing the number of trial participants.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up. In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

The Domino Effect… AU Federal Court Confirms Compulsory PBS Price Drop Knocks Price of Related Drugs

Aug 24, 2026

Gilead Sciences Pty Ltd v Minister for Health and Ageing [2026] FCA 232

Date of decision:	12 March 2026
Body:	Federal Court of Australia
Adjudicator:	Justice Downes

Introduction

In March this year, Justice Downes of the Federal Court of Australia delivered her decision in Gilead Sciences’ (Gilead) case against the Minister for Health and Ageing (the Health Minister). Finding against Gilead, her Honour held that once Alphapharm’s generic of Gilead’s Descovy® (which contains 2 antiviral compounds) is PBS listed, price reductions would also apply to Gilead’s Odefsey® and Biktarvy® (each containing the same 2 compounds plus another), and Genvoya® (containing the same 2 compounds, plus 2 others) under s 99ACC of the National Health Act 1953 (Cth) (the Act). Her Honour’s decision has wide-reaching implications for the pricing of combination drugs.

While Gilead has not appealed Justice Downes’ decision, the battle between Gilead and Alphapharm is far from over. In May 2026, Gilead Sciences commenced patent infringement proceedings against Alphapharm, seeking and then obtaining (by consent) an interlocutory injunction in July 2026 to prevent the PBS listing and launch of Alphapharm’s Dencovir®. These proceedings follow Gilead’s preliminary discovery application filed in March 2026 and resolved by consent orders later that month, with Alphapharm agreeing to provide Gilead with certain requested information regarding Dencovir®.

Background

The Legislation

Division 3A of the Act provides, amongst other things, that when the first generic brand of a pharmaceutical item is PBS listed, price reduction provisions will apply to brands of pharmaceutical items that are connected to the newly listed generic brand. In particular, pursuant to s 99ACC:

Price reductions apply to:
- an existing brand of a combination item, that is, in summary, a drug that contains at least 2 other drugs or medicinal preparations, at least one of which is a listed component drug; and
- a new generic brand of a pharmaceutical item that has that component drug which is listed for the first time.
On the day the price reduction takes effect, the approved ex-manufacturer price (AEMP) of the single brand of the combination item is reduced in accordance with the method set out in the regulations (namely, reg. 65A).

Gilead’s PBS Listed Products

Gilead has the following products listed on the PBS:

Descovy® (Emtricitabine + Tenofovir Alafenamide);
Odefsey® (Emtricitabine + Rilpivirine + Tenofovir Alafenamide);
Genvoya® (Tenofovir Alafenamide + Emtricitabine + Elvitegravir + Cobicistat); and
Biktarvy® (Bictegravir + Emtricitabine + Tenofovir Alafenamide).

Following Alphapharm’s listing of Dencovir® (a generic version of Descovy®) on the ARTG in January 2026, Gilead became concerned that Alphapharm would soon PBS list Dencovir®.

Key Issues

Both parties agreed that, if Dencovir® was listed on the PBS, Division 3A of the Act would have the effect that a first new brand price reduction would apply to Dencovir®, and the same price reduction would apply to Descovy® itself.

The key question on which the parties disagreed was: would the listing of Dencovir® result in price reductions for any other products which included emtricitabine and tenofovir alafenamide (i.e. Odefsey®, Genvoya® and Biktarvy®)?

Gilead argued that there should not be any price reductions for Odefsey®, Genvoya® and Biktarvy®; the Health Minister disagreed. Answering this question required Justice Downes to determine whether each of these products (i.e. Odefsey®, Genvoya® and Biktarvy®) is a combination item and whether the drug in each of them contains a listed component drug, namely “emtricitabine with tenofovir alafenamide”.

Gilead argued that if the Health Minister’s approach is correct, then reg. 65A (which provides the mechanism by which the price reduction is calculated) is invalid, stating that:

Reg. 65A does not provide any direction as to how to choose between the different possible combinations of a combination product’s constituents when selecting the components to which the formula in reg. 65A(2) is applied; and
as a result, the choice as to how to apply the formula was an entirely arbitrary one, generating different results depending on the choices made.

The Health Minister disputed Gilead’s position.

Consideration

Justice Downes analysed the statutory provisions and definitions. Her Honour held that the price reductions would apply to Odefsey®, Genvoya® and Biktarvy® under s 99ACC of the Act if Dencovir® was PBS listed because each of Odefsey®, Genvoya® and Biktarvy® is a combination item. Why? Because Odefsey®, Genvoya® and Biktarvy® are each a pharmaceutical that contains at least 2 other drugs, at least one of which is a listed component drug (namely, “emtricitabine with tenofovir alafenamide”). Her Honour also held that reg. 65A was not invalid. Why? Because her Honour considered that the manner in which reg. 65A works was not as stated by Gilead, and so rejected Gilead’s position.

Outcome and Implications

Gilead failed on all its arguments, with Justice Downes holding that the price reduction that would result if Dencovir® was to be listed on the PBS would also apply to Gilead’s Odefsey®, Genvoya® and Biktarvy®. Gilead was also ordered to pay the Health Minister’s costs.

Her Honour’s decision has wide-reaching implications for the pricing of combination drugs. The statutory price reductions which result from the listing of a generic product on the PBS will now impact the pricing of combination products that include the same listed component drug.

Her Honour’s decision also impacts innovator drug companies’ market enforcement strategies when faced with the imminent generic entry for a combination drug. Gilead has moved swiftly to protect its Australian market position by commencing patent infringement proceedings against Alphapharm in May 2026 and obtaining (by consent) an interlocutory injunction to prevent the PBS listing and launch of Alphapharm’s Dencovir®.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (Trans Tasman)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice. Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”. Ranked in Chambers Asia Pacific, Chambers Global, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ. Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees). In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

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Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand. Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

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Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

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Celltrion Launches Biosimilar Ustekinumab IV Formulation in Japan

Aug 21, 2026

On 21 August 2026, Celltrion announced that it has launched Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in an intravenous (IV) formulation in Japan.

Celltrion’s IV formulation of Steqeyma® was approved in Japan in April 2026, with the subcutaneous formulation launching in July 2025 following its March 2025 approval. Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, and the IV formulation is additionally approved for Crohn’s Disease.

Celltrion is one of a number of biosimilar competitors that have launched ustekinumab products in Japan, including, Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025) and Samsung Bioepis (May 2026).

Alvotech & Lotus Enter Licensing Agreement for Durvalumab and Emicizumab Biosimilars in the US and 8 Asian Markets

Aug 21, 2026

On 21 August 2026, Alvotech and Lotus Pharmaceutical announced that they have entered into a licensing and commercialisation agreement for Alvotech’s AVT34, biosimilar to AstraZeneca’s Imfinzi® (durvalumab), and AVT87, biosimilar to Roche/Genentech’s Hemlibra® (emicizumab), in the US and across eight Asian markets.

The agreement reportedly has a potential value for Alvotech of up to approximately US$150 million, based on upfront and milestone payments and ongoing revenues from the supply of commercial product.

Under the agreement, Taiwan-based Lotus has semi-exclusive commercialisation rights in the US, and exclusive commercialisation rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia.

Under the semi-exclusive agreement for the US Alvotech will commercialise both AVT34 and AVT87 in parallel to Lotus, with Lotus commercialising the products through its US-based wholly-owned subsidiary, Alvogen. Alvotech is responsible for development and marketing authorisations in the US, while Lotus has responsibility for local regulatory submissions and commercialisation in Asia.

Alvotech and Alvogen were each founded by Robert Wessman who remains the Chairman of both companies. Alvogen was acquired by Lotus in December 2025. Robert Wessman is the Chairman of the Board of Lotus.

Biosimilar development of durvalumab is at a very early stage globally, with Alvotech’s AVT34 being the first announced therapeutic durvalumab biosimilar in development.

Biosimilar emicizumab is being developed by CSPC Pharmaceutical Group, which announced in March 2026 that China’s National Medical Products Administration had approved clinical trials for its biosimilar emicizumab (SYS6053). Prestige BioPharma also has a preclinical emicizumab biosimilar in its pipeline.

PBAC Recommends Reimbursement for Ustekinumab & Aflibercept Biosimilars

Aug 21, 2026

On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:

Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to Janssen’s Stelara®, for first time PBS listing (5 mg/0.5 mL injection, 45 mg/0.5 mL and 90 mg/1 mL pre-filled syringe (PFS) and 130 mg/26 mL solution for IV infusion). Yesintek® was approved by the TGA in each of these presentations in April 2026.
Celltrion’s Steqeyma® (ustekinumab) for 3 new formulations (45 mg/0.5 mL vial, and 45 mg/0.5 mL and 90 mg/1 mL pre-filled pen (PFP)). Steqeyma® was the first ustekinumab biosimilar to be PBS listed on 1 August 2025 (45 mg/0.5 mL and 90 mg/1 mL PFS and 130 mg/26 mL solution for IV infusion).
Celltrion’s Eydenzelt® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2 mg, for four additional indications: subfoveal choroidal neovascularisation (CNV) due to age-related macular degeneration (AMD), diabetic macular oedema (DMO), branch retinal vein occlusion (BRVO) with macular oedema (MO) and central retinal vein occlusion (CRVO) with MO. Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV). Although recommended for PBS listing in November 2025 for the same indication, it has not yet completed the government processes required for PBS listing.

In addition to Steqeyma®, the only other ustekinumab biosimilar currently listed on the PBS is Amgen’s Wezlana®. Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time. Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.

Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting. Samsung Bioepis lodged documentation required for PBS listing on 10 July 2026, with the next step in the process (agreement on listing arrangements) having commenced on 14 July 2026. Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

The only Eylea® (aflibercept) biosimilar that is PBS listed in Australia is Sandoz’s Afqlir®, which was listed in February 2026 in vial and pre-filled syringe presentations for all reference indications.

Pearce IP Leaders Recommended in the 2026 Lexology Index for Intellectual Property

Aug 20, 2026

Two of Pearce IP’s leaders have been recommended by the Lexology Index: Intellectual Property 2026 which honours a small number of leading IP lawyers across 88 countries.

CEO and Founder, Naomi Pearce and Executive Helen Macpherson are recommended for Patents, and Copyright respectively.

The Lexology Index: IP is an in-depth guide to the international intellectual property legal market, recognising leading practitioners across patents, trademarks and copyright based on independent research and feedback from clients and peers.

Feedback from Lexology Index research includes:

“Naomi Pearce is a multiple-award winning principal and an inspiration to her team and to other lawyers….The size and strength of Naomi’s team and the quality of the clients and matters speaks volumes.”

Pearce IP’s Deputy CEO, Peter O’Sullivan, says:

“We are delighted to see both Naomi and Helen recognised in the Lexology Index: IP 2026. Naomi’s deep expertise and strategic insight in complex IP matters, particularly across the life sciences sector, and Helen’s broad IP expertise, including her work in copyright and plant breeders’ rights, reflect the exceptional depth of talent and capability within our team. Both are trusted advisers to clients navigating complex and commercially important IP challenges.”