Other Updates

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 announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), at the upcoming 2025 European Academy of Dermatology and Venereology Congress (EADV) to be held 17-20 September 2025.

A global phase 3 trial for Celltrion’s CT-P55 in patients with plaque psoriasis was approved by the FDA in August 2024.

Secukinumab biosimilars are also under development by Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024; phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

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 10 September 2025, Regeneron filed a patent infringement suit against Alvotech and Fisher Clinical Services UK Limited in the High Court of Justice for England & Wales.  The details of the allegations are not yet publicly available, but the dispute is reported to relate to Alvotech’s aflibercept biosimilar, Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech partnered with Advanz Pharma for the commercialisation of Mynzepli® into the UK and Europe.  Under the June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.  Mynzepli® was approved by the European Commission in August 2025 across all Eylea® indications, in pre-filled syringe and vial presentations, following a positive CHMP opinion in June 2025.

Fisher Clinical Services UK appears to be an end-to-end global clinical supply chain and logistics company based in the United Kingdom.

The UK lawsuit against Alvotech/Fisher was filed a day after Sandoz settled its US aflibercept litigation with Regeneron.  Regeneron remains in US BPCIA litigation against each of Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42) regarding aflibercept biosimilars.  Preliminary injunctions were granted preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Biocon and Regeneron settled US BPCIA litigation regarding aflibercept in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™, in the second half of 2026, or earlier under certain undisclosed circumstances.

The only biosimilar aflibercept currently available in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.

On 9 September 2025, Sandoz announced that it has settled all US patent disputes with Regeneron relating to Sandoz’s Enzeevu®, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the settlement, Sandoz is permitted to launch its biosimilar aflibercept in Q4 2026, or earlier in certain undisclosed circumstances.

Regeneron commenced BPCIA litigation against Sandoz in the US District Court for the District of New Jersey on 26 August 2024, asserting infringement of 46 US patents relating to aflibercept.  The Court filing came two weeks after the FDA approved Sandoz’s Enzeevu® (aflibercept-abzv) for treatment of nAMD.

The Sandoz US proceeding was one of many Regeneron US proceedings regarding aflibercept biosimilars.

• Biocon and Regeneron settled US aflibercept BPCIA litigation in April 2025, paving the way for a US launch of Biocon’s biosimilar, Yesafili™, in the second half of 2026, or earlier under certain undisclosed circumstances. Litigation remains pending against Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203) and Celltrion (2 actions, CT-P42).
• Preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (in June 2025).

On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent.

The interlocutory injunction application was heard on 14 August 2025 with Justice Rofe announcing her decision on 3 September 2025 and publishing her reasons for judgment on 8 September 2025.  Justice Rofe found an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement, with PBS listing to commence from 1 December 2025.  Sandoz indicated during the court proceeding that while Afqlir® will be launched in Australia in the coming months, it does not intend to launch Enzeevu® in 2025.

Subject to any settlement, the case will now proceed to a hearing for final relief.

Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, has filed legal proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter scheduled for 8 October 2025.

Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron’s aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.  Regeneron/Bayer have indicated that they may wish to seek an interlocutory injunction in relation to that patent, depending on the outcome of the preliminary discovery application.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu®.  Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.

On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”) as a first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer (NSCLC).  Atezolizumab and cemiplimab (including “quality assured biosimilars”) are listed as therapeutic alternatives to pembrolizumab for metastatic NSCLC.

The WHO Model Lists are updated every two years and are intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists.  Essential medicines are those considered to satisfy the priority health care needs of a population.

Amongst the biopharmaceuticals added to the Model List this year, ustekinumab and adalimumab (with certolizumab pegol, etanercept and infliximab as therapeutic alternatives) were also added to a complementary list (medicines for which specialised monitoring, diagnostics or care are required) for the treatment of adults and children with moderate-to-severe psoriasis.  Emicizumab has been included on the Model List for Haemophilia A.

MSD’s Keytruda® (pembrolizumab) has been approved in multiple jurisdictions for multiple cancer-related indications.  In August 2025, Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos.  A number of pembrolizumab biosimilars are currently in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.

No biosimilars to Roche’s Tecentriq® (atezolizumab) or Regeneron and Sanofi’s Libtayo® (cemiplimab) have been approved to date.

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 4 September 2025, Brazil’s National Health Surveillance Agency (Anvisa) announced that it seized a batch of a drug sold under the name Opdivo®, after medicine registration owner Bristrol-Myers Squibb notified Anvisa that the batch was not known to be genuine.

Counterfeit Opdivo® has previously been reported in the USA, resulting in a United States federal grand jury indicting a person from India for allegedly selling the counterfeit cancer drugs and shipping them to Houston.

As previously reported in the context of counterfeit supply of Novo Nordisk’s semaglutide products Ozempic® and Wegovy® in the US, counterfeit drugs are often combated by civil lawsuits.  When a counterfeit product contains no active ingredient, patent protection is unlikely to apply and any civil suit would need to rely instead on trade mark rights, fair trading laws and other related law applicable in the relevant jurisdiction.  It is not known whether any manufacturer will file a civil suit in relation to this case.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.