On 27 November 2025, India’s Medical Dialogues reported that Intas Pharmaceuticals has received approval in India to conduct a phase I trial comparing its INTP78 combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.  Intas already has approval to market its biosimilar pertuzumab in India and, through its subsidiary Accord BioPharma, biosimilar trastuzumab in the USA.

There has been significant activity in relation to biosimilars to pertuzumab and trastuzumab as separate treatments.  Amgen has previously conducted trials on the combination.

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

On 25 November 2025, Prestige Biopharma announced that it has entered into an exclusive license and supply agreement with Biosidus for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a variety of Latin American markets including Argentina, Mexico, Bolivia and Paraguay.

Under the agreement, Biosidus will have exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, while Prestige will be responsible for the production and supply through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia.

The agreement follows a separate licence agreement entered into by Prestige and Teva for the commercialisation of Tuznue® across a majority of European markets.  Under that agreement, Teva is responsible for marketing and distribution Tuznue® in a majority of European markets, while Prestige is responsible for production and supply, also through its EU-GMP-certified facilities.

Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024, which landmarked the first major adoption of the product on the global stage.

On 30 October 2025, Celltrion announced that, according to IQVIA, its Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), has achieved 50% market share in Japan, surpassing competing innovator and biosimilars to become that top bevacizumab product.  Celltrion states that Vegzelma® has more than tripled its market share, which stood at 15% the same time last year.

Vegzelma®’s success follows that of Celltrion’s other oncology biosimilar, Herzuma®, referencing Roche’s Herceptin® (trastuzumab), which holds a 74% market share in Japan.  Celltrion further reports that its autoimmune disease portfolio has shown strong performance, with Remsima®, referencing Janssen’s Remicade® (infliximab), and Yuflyma®, referencing AbbVie’s Humira® (adalimumab), achieving market shares of 43% and 14%, respectively.

Celltrion attributes this growth to the success of its localised sales and distribution strategy, tailored to Japan’s Diagnosis Procedure Combination (DPC) system, a reimbursement framework that encourages the use of cost-effective medicines such as biosimilars.

In September 2025, Celltrion announced that its Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), became the first biosimilar tocilizumab approved in Japan.  This followed the Japanese launch of Celltrion’s biosimilar ustekinumab, Steqeyma®, referencing J&J/Janssen’s Stelara®, in July 2025.

On 20 October 2025, Teva announced that it has entered into a licensing agreement with Prestige Biopharma for the commercialisation of Tuznue®, biosimilar to Roche’s Herceptin® (trastuzumab), across a majority of European markets.

Under the agreement, Teva will market and distribute Tuznue® in a majority of European markets, while Prestige Biopharma will be responsible for production and supply through its EU-GMP-certified, high-tech facilities equipped with advanced single-use technology.  Tuznue® was approved by the European Medicines Agency in September 2024, following the adoption of a positive opinion in July 2024.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), followed by Celltrion’s Herzuma® (February 2018), Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Biocon’s Ogivri® (December 2018), Henlius/Accord’s Zercepec® (July 2020), and Sandoz’s Herwenda® (November 2023).

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.  The agreement includes the following biologics:

• Avastin® (bevacizumab) for ocular conditions only. This represents a rare example of Pharmac funding two suppliers’ brands of the same biologic.  Celltrion’s bevacizumab biosimilar, Vegzelma®, was awarded Principal Supply Status for all reference indications by Pharmac in February 2025.  However, the agreement with Celltrion specifically allowed other brands to be funded for ocular conditions only.
• Ocrevus® SC (ocrelizumab), alongside IV Ocrevus®. Most patients are expected to switch to Ocrevus® SC.  No ocrelizumab biosimilars have been submitted for approval in New Zealand to date.
• Phesgo® (pertuzumab and trastuzumab) for subcutaneous treatment of HER2-positive metastatic breast cancer. Roche’s Perjeta® (pertuzumab) and Celltrion’s Herzuma® (biosimilar trastuzumab) are already funded as separate IV infusions for people with HER2-positive metastatic breast cancer.  It is expected that most patients receiving these in combination will now receive Phesgo® as it can be administered faster than the IV infusions, providing the same treatment benefit with less time spent receiving treatment.
• Vabysmo® (faricimab) for diabetic macular oedema and wet age-related macular degeneration. Funding criteria will be the same as updated criteria for aflibercept (Regeneron’s Eylea®).  Criteria for funding ranibizumab are also being updated.
• Gazyva® (obinutuzumab) and MabThera® (rituximab) will have funding criteria updated. No MabThera® biosimilar is currently funded for rheumatoid arthritis to date due to Roche patent protection subsisting in New Zealand for that indication.  Sandoz’s biosimilar rituximab, Riximyo®, is funded for all other (off-patent) indications.

Submissions on the provisional agreement may be made until 5.00pm 8 October 2025 (NZ time).

On 28 August 2025, Celltrion announced that it has launched two biosimilars in Vietnam:

• Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab); and
• Herzuma®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).

Alongside this launch, Celltrion states that it has secured a one-year supply agreement for Remsima® SC with the largest military hospital in Vietnam and a two-year tender to supply Herzuma® to medical institutions in the central and southern regions of the country.

Celltrion has successfully tendered for the supply of Remsima® and Herzuma® in a number of key regions over the past two years, including Brazil (September 2024), and of Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).

In February 2024, Celltrion secured a series of tenders in Peru to supply Herzuma® (trastuzumab biosimilar), Truxima® (rituximab biosimilar) and Yuflyma® (adalimumab biosimilar).  In June 2024, Celltrion successfully applied to be the exclusive supplier of Remsima®, Herzuma® and Vegzelma® (bevacizumab biosimilar) to France’s largest pharmaceutical procurement group (Union des Hopitaux pour les Achats (UniHA)), until 2027.

Earlier this month, Celltrion’s Remsima® IV formulation was recommended for listing on Australia’s Pharmaceutical Benefits Scheme for reimbursement.  Remsima® IV was approved by Australia’s TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).

On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), for the treatment of HER2-positive breast or gastric cancer.

In July 2025, Dazublys® was approved in the EU for the same indication following the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in April 2025.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017).  Other trastuzumab biosimilars since approved in the UK include Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Celltrion’s Herzuma® (January 2021), Biocon’s Ogivri® (January 2021) and Organon’s Ontruzant® (January 2021).

On 2 July 2025, The Economic Times reported that Aurobindo Pharma’s wholly owned subsidiary, CuraTeq Biologics, has received marketing approval from the European Commission for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab).  The authorisation follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of Dazublys® for the treatment of HER2-positive breast or gastric cancers.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017), while Mylan/Biocon’s Ogivri® was the first to be approved in the US (December 2017).

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars.  Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab.  The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).