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

On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.   

For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments. 

Four biosimilars will be considered for new listings: 

• Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis 

• Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis 

• Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria 

• Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease 

One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). 

Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following: 

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales.  Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab.  Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023).  It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and  Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US.  Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November.  Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023),  CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants.  Celltrion reports that the study found Zymfentra™ as monotherapy was just as effective and safe as when combined with immunosuppressants for patients with Crohn’s disease or ulcerative colitis, suggesting “monotherapy can be a sufficiently safe and effective treatment option”.  The results were presented at the 2024 American College of Gastroenterology conference (25-30 October 2024).

This news follows Celltrion’s 19 August 2024 announcement that the FDA has approved a phase 3 clinical trial of Zymfentra™ for rheumatoid arthritis.

Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA for ulcerative colitis and Crohn’s disease in October 2023.  It was launched in the US in March 2024.

In Europe, Zymfentra™ is known as Remsima SC® and has been approved since 2013.

On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease, refractory fistulising Crohn’s disease and ulcerative colitis.

This is the second approval for a Pfizer-sponsored infliximab biosimilar, with Inflectra® having been the first infliximab biosimilar approved in Australia in November 2015.

On 26 September 2024, the TGA provisionally approved Janssen’s Talvey® (talquetamab) in 2mg/ml and 40mg/ml solutions for injection vial for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.  Talvey® was granted accelerated approval in the US by the FDA in August 2023.

Also on 26 September 2024, Celltrion’s Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), received Australian approval for a lower dose of 20mg/0.2ml solution for injection pre-filled syringe.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (30 June 2023) forms and was PBS listed in March 2023 (40mg/0.4ml).

On 13 September 2024, Celltrion announced it has won the contract to supply Herzuma® (trastuzumab), biosimilar to Roche’s Herceptin®, to the Brazilian Federal Government to the end of 2025.  Celltrion will supply 660,000 vials of the biosimilar during the fifth consecutive year that it has held the government contract.  It claims that Herzuma® is the most prescribed trastuzumab drug in Brazil and accounts for more than 50% of the market annually.

Celltrion also reports that it recently succeeded in winning the bid to supply Remsima® (infliximab), biosimilar to J&J’s Remicade®, to the Brazilian Federal Government for the third consecutive year.  Last month, it was asked to supply 25% more vials of the drug than originally contracted.

This follows Celltrion’s recent tender successes regarding Remsima® and Herzuma® in Peru (May 2024) and Remsima SC® in Denmark (April 2024), Norway (February 2024) and Sicily (January 2024).  In February 2024, Celltrion also 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.

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

Celltrion announced on 19 August 2024 that the FDA has approved a phase 3 clinical trial of Zymfentra™ (CT-P13 SC, infliximab SC) for rheumatoid arthritis (RA).

In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for ulcerative colitis and Crohn’s disease.  Celltrion launched Zymfentra™ in the US in March 2024.

Zymfentra™ is known as Remsima SC® in Europe.  Remsima SC® has been approved in Europe since 2013.

On 9 August 2024, Celltrion announced that its Zymfentra^™  (infliximab-dyyb) has been included in 26 US formularies, including for 3 major Prescription Benefit Managers (PBMs), just five months after launch.  According to Celltrion, the formulary listings provide 75% of coverage across the entire US insurance market.

In October 2023, Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA, for ulcerative colitis and Crohn’s disease.  Celltrion launched Zymfentra^TM in the US in March 2024.

Zymfentra^TM is known as Remsima SC® in Europe.  Remsima SC® has been approved in Europe since 2013.