On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.

Sandoz has suspended its Phase 3 trial for JPB898, biosimilar to BMS’ Opdivo® (nivolumab), administered in combination with Yervoy® (ipilimumab) in patients with unresectable Stage III or metastatic Stage IV melanoma.  It is modifying its Phase 1/3 trial for CYB704, biosimilar to Genentech’s Ocrevus® (ocrelizumab), so that it will become a comparative pharmacokinetic trial.

Sandoz’s decision to streamline its nivolumab and ocrelizumab clinical trials follows its April 2025 announcement that it is “minimising” its Phase 3 trial of GME751, biosimilar to MSD’s Keytruda® (pembrolizumab), in patients with untreated metastatic non-squamous NSCLC.  Sandoz is continuing its Phase 1 trial of the pembrolizumab biosimilar in patients with resected advanced melanoma.

In February 2025, Formycon similarly announced the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®.  According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206.  Instead, Formycon will be relying on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older.  With this approval, Avtozma® IV now aligns with all reference indications of Actemra® IV in the US.

Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS-listing at PBAC’s November 2025 meeting.

On 6 August 2025, Intas Pharmaceuticals, and its global subsidiaries operating under the Accord brand, announced the successful acquisition of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), from Coherus Biosciences.  The addition of Udenyca® expands Intas and Accord’s biosimilar portfolio, which already includes Accord’s other biosimilar pegfilgrastim, Pelgraz®.

The successful acquisition of Udenyca® follows announcement of the agreement for its sale in December 2024 under which Coherus would receive USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance.

In March 2025, Coherus further announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma.  The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court.  While the details of the proceedings have not yet been published, it is expected that the proceedings are likely to relate to one or more Australian patents regarding Regeneron/Bayer’s Eylea® (aflibercept).  The first case management hearing in the proceeding is listed for 8 September 2025.

If the litigation commenced by Actor does relate to aflibercept, it will not be the first Australian aflibercept litigation.  On 4 June 2025, Regeneron and Bayer filed proceedings in the Federal Court against Sandoz alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Regeneron is seeking both an interlocutory injunction and final relief, with the hearing of the interlocutory injunction scheduled for 14 August 2025.  Regeneron/Bayer have also filed an application for preliminary discovery in relation to a second of Regeneron’s Australian aflibercept patents, scheduled for hearing on 27 August 2025.

Actor does not currently have any aflibercept biosimilars registered in its name on the ARTG.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.

On 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  PB016 was developed by Polpharma, which will remain responsible for manufacture.  Fresenius Kabi will be responsible for commercialisation.

In February 2024, Polpharma Biologics announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  Phase 3 trials comparing PB016 to Entyvio® are underway, with estimated completion in September 2025.

There are a number of other vedolizumab biosimilars in development.  In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)).  In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.

On 5 August 2025,  CivicaScript, LLC announced that it will distribute Fresenius Kabi’s unbranded ustekinumab-aauz, biosimilar to J&J/Janssen’s Stelara®, in the US from 1 January 2026.  CivicaScript is a nonprofit company dedicated to bringing low-cost generic medicines to US patients, and will be the exclusive distributor of Fresenius Kabi’s unbranded ustekinumab-aauz.

Fresenius Kabi has already launched its branded ustekinumab biosimilar, Otulfi®, in the US in March 2025 and in Canada in May 2025.  Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024 and in Canada and the UK in January 2025.  It is being commercialised in Canada, the US, and most of Europe by Fresenius Kabi under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In August 2023, Formycon and Fresenius reached a settlement with J&J in the US, enabling US launch of FYB202 “no later than 15 April 2025” (the biosimilar’s US launch was in early March 2025).  This was followed by a settlement in March 2024 regarding the commercialisation of FYB202/Otulfi® in Europe and Canada, with the launch dates in those countries previously undisclosed.

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 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders.  Fresenius is seeking to overturn claims 1-5, 7-30, and 32-50 of the 865 patent based on anticipation, and all claims of the 345 patent based on anticipation and obviousness.

Samsung Bioepis, Formycon and Celltrion had previously also challenged the validity of Regeneron’s US 11,084,865 before the USPTO, filing petitions for IPR in November 2024, December 2024 and January 2025, respectively.  On 2 June 2025, the PTAB denied institution of Samsung Bioepis’ and Formycon’s petitions, including because the 865 patent is already the subject of pending BPCIA litigation involving the parties.  Celltrion’s petition was denied on 26 June 2025 for similar reasons.  Notably, Fresenius is not currently a party to any BPCIA aflibercept litigation brought by Regeneron.

Regeneron is in BPCIA litigation against each of Amgen (Pavblu™), Samsung Bioepis (2 actions; Opuviz™/SB15), Formycon (Ahzantive®/FYB203), Celltrion (2 actions, CT-P42) and Sandoz (Enzeevu™) regarding biosimilar aflibercept.  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).

Fresenius entered into a licensing agreement with Sam Chun Dang in December 2024 for the exclusive commercialisation of SCD-411, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), in the US and various South American countries.  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).  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.

On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up 3% on the previous quarter and now only one percentage point behind the leading product.

Celltrion stated that this is a “significant achievement” given that Yuflyma® joined the top prescription tier three years later than its competitors and in a “highly competitive market with over 10 adalimumab products”, including originator product Humira®.

In April 2025, Celltrion announced that it secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free presentation of Yuflyma®.  There are a number of high concentration adalimumab biosimilars approved in the US, including: Samsung Bioepis’ Hadlima™, Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Boehringer Ingelheim’s Cyltezo®.