Biosimilars Deals 2021 Archives | Page 2 of 8

Sandoz Streamlines Clinical Trials for Nivolumab and Ocrelizumab Biosimilars

Aug 7, 2025

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”.

New Indication Alert: FDA Approves Celltrion’s Biosimilar Tocilizumab IV Formulation for CRS

Aug 6, 2025

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.

Intas and Accord Acquire Pegfilgrastim Biosimilar from Coherus Biosciences

Aug 6, 2025

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.

Pearce IP BioBlast® for the week ending 1 August 2025

Aug 5, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 1 August 2025 are set out below:

Aflibercept, Denosumab, Tocilizumab

30 July 2025 | AU | Four Celltrion Biosimilars on November PBAC Agenda in AU

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered… Read more here.

Denosumab

2 August 2025 | IN | Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO

As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas… Read more here.

1 August 2025 | AU | Sandoz’s Denosumab and Celltrion’s Ustekinumab & Omalizumab PBS-Listed in AU

On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following… Read more here.

Nivolumab, Ipilimumab

25 July 2025 | TW | New Indication Alert: Opdivo®/Yervoy® Combo Approved in Taiwan for HCC

On 25 July 2025, Ono Pharmaceutical Co announced the additional approval by the Taiwan Food and Drug Administration (TFDA) of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) as… Read more here.

Pertuzumab

25 July 2025 | IN | High Court of Delhi Declines to Order Zydus to Disclose Pertuzumab Biosim Manufacturing Process

On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to… Read more here.

Pertuzumab, Omalizumab

24 July 2025 | Roche Revises Expectations of Biosimilar Competition to Pertuzumab and Omalizumab

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… Read more here.

Biosimilar Deals

30 July 2025 | FR | Sandoz to Acquire Just-Evotec’s Development & Manufacturing Facility for USD 300M

On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics… Read more here.

29 July 2025 | US | Celltrion Preferred Bidder for US Biologics Manufacturing Plant

On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global… Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

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

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Lawyer

Nathan is a lawyer focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

Actor Commences Legal Action Against Regeneron/Bayer in Australia

Aug 5, 2025

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.

Fresenius Kabi takes Global Licence to Polpharma’s Vedolizumab Biosimilar

Aug 5, 2025

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.

Fresenius Kabi to Launch Unbranded Ustekinumab Biosimilar in US via CivicaScript

Aug 5, 2025

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.

Kashiv & MS Pharma Enter Licensing Deal for Biosimilar Omalizumab in MENA Region

Aug 5, 2025

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.

Celltrion’s Omalizumab PFP Approved in AU

Aug 4, 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.

Update on Challenges to Regeneron’s US Aflibercept Patents

Aug 4, 2025

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.

Celltrion’s Adalimumab Vying for Top Spot in EU

Aug 4, 2025

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®.

Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO

Aug 2, 2025

As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar. In the CSR, data was presented from a randomised Phase I trial for Intas’ 120 mg / 1.7 mg denosumab injection.

Sandoz’s Denosumab and Celltrion’s Ustekinumab & Omalizumab PBS-Listed in AU

Aug 1, 2025

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.

Boryung Launches Samsung Bioepis’ Xbryk™ (Denosumab) in South Korea

Aug 1, 2025

On 1 August 2025, the Korea Biomedical Review reported that Boryung launched Samsung Bioepis’ denosumab biosimilar (Xbryk™) in the Korean market, following its regulatory approval in May 2025. Xbryk™ is a biosimilar to Amgen’s Xgeva® and is approved to prevent skeletal complications in patients with bone metastases and to treat giant cell tumour of bone.

Samsung Bioepis and Boryung announced on 2 July 2025 that they entered into an exclusive licensing deal in relation to Xbryk™, one day after Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024). In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®. Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

Sandoz to Acquire Just-Evotec’s Development & Manufacturing Facility for USD 300M

Jul 30, 2025

On 30 July 2025, Sandoz and Evotec announced that they have signed a non-binding term sheet relating to Sandoz’s potential acquisition of Just-Evotec Biologics EU and its J.POD® biologics manufacturing facility in Toulouse, France. Under the proposed arrangement, Sandoz would also be granted access to Evotec’s proprietary platform for integrated development and advanced continuous manufacturing of biologics via a technology licence.

The proposed transaction would result in Sandoz acquiring 100% of the issued and outstanding equity interest of Just-Evotec for approximately USD 300 million. According to Evotec, the deal will further encompass additional technology related consideration, future development revenues, milestones and product royalties.

Sandoz intends to use the Toulouse site to develop and manufacture Sandoz biosimilars, reinforcing its in-house biosimilar capabilities, while creating additional strategic flexibility. Upon completion of the proposed transaction, Just-Evotec’s employees would transfer with the acquired entity and would become part of the Sandoz Group. Finalisation of the proposed transaction is subject to negotiation of contractual details and obtaining necessary approvals.

Sandoz and Just-Evotec have partnered in relation to the development and manufacturing of biosimilars since May 2023. That partnership was expanded in July 2024.

On 1 July 2025, Sandoz announced that it had commenced construction of a new biosimilar production centre in Slovenia, due to open in 2028, to expand Sandoz’s European biosimilar manufacturing capacity.

Four Celltrion Biosimilars on November PBAC Agenda in AU

Jul 30, 2025

On 30 July 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its November 2025 agenda, at which four Celltrion biosimilars will be considered:

Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg), for all reference indications;
Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), for all reference indications; and
Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for all reference indications.

Biosimilar aflibercept

Celltrion’s Eydenzelt® (approved March 2025) is the second aflibercept biosimilar to be considered by PBAC, following Sandoz’s aflibercept biosimilars Afqlir® and Enzeevu™, which were approved in May 2025 and considered by PBAC in July 2025. The outcomes of the July 2025 meeting have not yet been published. Beyond those of Sandoz and Celltrion, there are no other aflibercept biosimilars approved in Australia.

Biosimilar denosumab

In December 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). Jubbonti® and Wyost® were the first denosumab biosimilars approved in August 2024, followed by Celltrion’s Stoboclo® and Osenvelt® (April 2025) and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025). In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia. In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

Biosimilar tocilizumab

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

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).

Celltrion Preferred Bidder for US Biologics Manufacturing Plant

Jul 29, 2025

On 29 July 2025, in a report to its shareholders, Celltrion announced that it has been designated as the preferred bidder for an undisclosed large-scale cGMP US manufacturing plant owned by a global pharmaceutical company. Celltrion is expecting to complete the acquisition in early October 2025.

According to Celltrion, the US manufacturing plant acquisition is part of its “US tariff response strategy”. Celltrion’s strategy to minimise the impact of “US pharmaceutical tariff policies” also includes stockpiling of two years’ worth of inventory within the US and expanding contracts with local CMO companies to enable US domestic production of products sold in the US.

Celltrion expects the acquisition of the US manufacturing facility to have additional benefits, including strengthening its market responsiveness and generating immediate revenue due to an agreement that will permit Celltrion to use half the plant’s capacity to exclusively produce the current plant owner’s biologics for the next 5 years.

Pearce IP BioBlast® for the week ending 25 July 2025

Jul 29, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 25 July 2025 are set out below:

Aflibercept, Denosumab, Ustekinumab

25 July 2025 | EU | Positive CHMP Opinions for Henlius’ Denosumab, Alteogen’s Aflibercept and Biocon’s Ustekinumab

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars… Read more here.

Daratumumab

23 July 2025 | EU | New Indication Alert: Janssen’s Daratumumab EU Approved for SMM

On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the… Read more here.

Denosumab

23 July 2025 | EU | Fresenius Kabi’s Denosumab Biosimilars Approved in Europe

On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference… Read more here.

16 July 2025 | US | Accord/Intas’ Biosimilar Denosumab Set for Oct 2025 US Launch Following Settlement with Amgen

On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab… Read more here.

Etanercept

23 July 2025 | AU | Biocon Biologics Launches Biosimilar Etanercept in Australia

On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia. Nepexto® was approved by Australia’s… Read more here.

Nivolumab, Ipilimumab

24 July 2025 | US | PTAB Institutes Amgen’s IPR Against BMS’ Nivolumab/Ipilimumab Colorectal Cancer Treatment Patent

On 24 July 2025, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review (IPR), filed by Amgen in February 2025, challenging the validity of a BMS US patent (US11332529) relating… Read more here.

Biosimilar Policy

21 July 2025 | US | Samsung Bioepis Publishes Tenth US Biosimilar Market Report; Considers US MFN Policy May Reduce Biosimilar Competition

On 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale… Read more here.