On 11 March 2026, Celltrion announced the European launch of its Remsima® IV liquid formulation, biosimilar to Janssen’s Remicade® (infliximab).  This follows the November 2025 approval of Remsima® IV liquid formulation by the European Commission for the treatment of rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The company has completed patent registrations in most European countries including the UK, Germany and France.  Celltrion has secured national tenders in Denmark and Norway for the Remsima® IV liquid formulation, with sales expected to commence in Norway immediately following the contract award.

The launch of the IV liquid formulation of infliximab aligns with Celltrion’s broader strategy of focusing on formulation-based differentiation announced earlier this year.  This launch completes Celltrion’s full line up of infliximab products, which includes the world’s first subcutaneous infliximab solution product and an IV powder formulation.

Remsima® IV powder formulation was first approved in Europe in 2013 and launched across major European countries in early 2015.  The subcutaneous formulation, Remsima® SC, received European approval in 2019 and was launched in the EU in 2020.  In February 2024, Celltrion launched Remsima® SC in the US under the brand name Zymfentra®.

Several other infliximab biosimilars have been approved around the world, including Hospira/Pfizer/Celltrion’s Inflectra® in the EU, Canada, New Zealand and USA; Samsung Bioepis’s Flixabi® in the EU and Renflexis® in Australia, New Zealand and the USA; Pfizer’s Ixifi® in Australia, New Zealand and the USA; Biocad’s BCD-055 in Russia; Sandoz’s Zessly® in the EU; and Amgen’s Avsola® in the USA.

On 2 December 2025, Celltrion announced that it has launched Remsima® SC (infliximab) in Chile, marking the biosimilar’s first entrance into the public market in Central and South America.

Remsima® SC was first listed on the Chilean public insurance plan in April 2025 and Celltrion Chile has recently completed its first sales following negotiations with the local public procurement agency, CENABAST.  According to Celltrion, the public market accounts for 80% of pharmaceutical product sales in Latin America.

Celltrion’s Remsima®, biosimilar to Janssen’s Remicade® (infliximab), has been approved in Europe since 2013 and was launched in major European countries in early 2015.  Subcutaneous infliximab (Remsima™ SC) first received European approval in November 2019 and was launched in the EU in 2020.  In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US.  In November 2025, Celltrion announced that its Remsima® IV liquid formulation was approved in Europe.

On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the powder formulation, including rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.  According to Celltrion, the product is the world’s first liquid formulation of IV infliximab.

Celltrion’s Remsima®, biosimilar to Janssen’s Remicade® (infliximab), has been approved in Europe since 2013 and was launched in major European countries in early 2015.  Subcutaneous infliximab (Remsima™ SC) first received European approval in November 2019 and was launched in the EU in 2020).  In February 2024, Celltrion launched Remsima SC® as Zymfentra® in the US.

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 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 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu™, have been recommended for PBS-listing under the same circumstances as reference biologic, Regeneron/Bayer’s Eylea®.  Sandoz’s 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.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).

Biocon Biologic’s Nepexto® (pre-filled syringe), biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was also recommended for PBS-listing (sponsor: Maxx Pharma).  Nepexto® (50mg/1ml auto-injector) became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.  In July 2025, Biocon Biologics announced that it launched Nepexto® in Australia.

Celltrion’s Remsima® (IV formulation), biosimilar to Janssen’s Remicade® (infliximab), has also been recommended by PBAC.  Remsima® IV was approved by the TGA in November 2015, while Remsima® SC received approval in November 2020 (PBS-listed July 2021).

Among the originator biopharmaceuticals, Roche/Genentech’s Ocrevus® (ocrelizumab) SC formulation was recommended for PBS listing under the same circumstances as the IV formulation, following its approval in Australia in March 2025.

There are a number of ocrelizumab biosimilars currently in development.  On 7 August 2025, Sandoz announced that it is streamlining the clinical development programs for its nivolumab and ocrelizumab biosimilars, which includes modifying its Phase 1/3 trial for biosimilar ocrelizumab, CYB704, so that it will become a comparative pharmacokinetic trial.  In January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) undergoing Phase 3 trials.  Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab).

On 21 August 2025, New Zealand’s Medsafe approved Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), in 100mg IV formulation for all reference indications.

Ixifi® will be the second infliximab biosimilar available in New Zealand, following Celltrion’s Remsima® (SC formulation, 120mg/ml pre-filled pen and pre-filled syringe), approved in June 2023.

Pfizer’s Inflectra® branded infliximab biosimilar (100mg IV formulation) was initially approved by Medsafe in September 2015, but the company no longer supplies or markets the product.  Similarly, Samsung Bioepis’ infliximab biosimilar, Renflexis® (100mg IV formulation), was approved by Medsafe in March 2023, but is also no longer supplied or marketed in New Zealand.

Pfizer and Celltrion entered into a 2009 agreement for biosimilar infliximab, with Pfizer holding exclusive commercialisation rights in the US and certain other jurisdictions.  In March 2025, Celltrion announced the rebrand of Inflectra® (IV formulation) to Remdantry™ in Canada.  According to Celltrion, the rebrand reflected its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

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 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025.  The formulation, indications and dosages of Remdantry™ will remain the same as those for Inflectra®.

According to Celltrion, the rebrand reflects its “consolidation of both the intravenous (IV) and subcutaneous (SC) formulations” being directly commercialised by Celltrion in Canada in order to “provide healthcare professionals with a more streamlined prescribing experience”.

Inflectra®, biosimilar to Janssen’s Remicade®, was approved by Health Canada for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in January 2014 and for Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) in June 2016.

Celltrion’s SC infliximab, Remsima™ SC, was approved by Health Canada for RA in January 2021 and for UC and Crohn’s disease in February 2024.

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases
• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis.

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s Imfinzi® for use in combination with platinum-based chemotherapy for the treatment of deficient mismatch repair (dMMR) endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer.

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations.

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma.

The PBAC reports that some earlier recommendations have been extended:

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis and uncontrolled severe asthma

Additionally, two recommendations have been rescinded:

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis
• AbbVie’s Skyrizi® (risankizumab) for Crohn’s disease