On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  This follows interchangeability designation for Hadlima™ in low-concentration prefilled syringe and single-dose vial presentations granted in June 2024.  According to Samsung Bioepis, with this latest designation, Hadlima™ is now fully interchangeable with Humira®.

A few days earlier, on 23 May 2025, Celltrion announced that the US FDA has granted an expanded interchangeable designation for its high concentration adalimumab biosimilar, Yuflyma® (adalimumab-aaty), to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  This follows interchangeability designation granted to its high-concentration 20mg and 80mg pre-filled syringe presentations in April 2025.  According to Celltrion, Yuflyma® is now fully interchangeable with Humira® across all of Yuflyma®’s marketed dosage forms and strengths.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

On 14 April, Celltrion announced that it has secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free adalimumab biosimilar, Yuflyma® (adalimumab-aaty).

Celltrion’s high concentration formulation was first approved by the FDA in May 2023, and the company applied for interchangeable status in January 2024.

The first high concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.

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®.

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 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).

A number of biopharmaceuticals and biosimilars are potentially in line for September listings on Australia’s Pharmaceutical Benefits Scheme (PBS).

UCB’s Bimzelx® (bimekizumab) has progressed to the last stage before PBS listing for psoriatic arthritis and ankylosing spondylitis (the drug is already subsidised for chronic plaque psoriasis). AstraZeneca and Daichii Sankyo are looking to expand Enhertu® (trastuzumab deruxtecan) for HER2-low unresectable or metastatic breast cancer.  Bimzelx® and Enhertu® were both recommended for listing on the PBS for these indications by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in April this year.

GSK’s Nucala (mepolizumab) may see its clinical criteria for the treatment of unresolved severe asthma amended to remove the oral corticosteroids requirement to bring it in line with current treatment guidelines.

As for biosimilars, there are possible changes to two biosimilars to Abbvie’s Humira® (adalimumab).  Following PBAC recommendations in March 2024, Organon may add a PBS-listing for a 40 mg in 0.4 ml PFP of Hadlima® (adalimumab-bwwd) and Celltrion may add 80 mg in 0.8 ml PFN and PFS of Yuflyma® (adalimumab-aaty).

On 12 August 2024, Celltrion announced that its high concentration, buffer free (100mg/ml) adalimumab, biosimilar to AbbVie’s Humira®, is now on the Costco member prescription program.  The Celltrion buffer free product was FDA approved on 23 May 2023 and was launched in the US on 2 July 2023.  The product was first available in Costco Speciality Pharmacy on 1 October for self-funded employer plans, and is now available for all Costco members through the membership prescription program.  Celltrion had previously announced the “exclusive” supply of its Yuflyma® through Care Partners, which is apparently at odds with the Costco deal.

This follows the news on 18 July 2024 that GoodRx listed Boehringer Ingelheim’s low and high concentration adalimumab products for supply at a 92% discount from Humira, which in turn followed a similar deal between Alvotech and Cigna subsidiary Quallent Pharmaceuticals in April 2024.

Earlier this year, Celltrion applied to the FDA seeking interchangeable status for Yuflyma®.  Celltrion has previously said that it “tentatively expects” interchangeability designation to be granted in Q4 2024.  Alvotech and Teva’s Simlandi® received FDA approval on 23 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA.

On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.

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

• Amgen’s Wezlana® (ustekinumab); and
• Celltrion’s Yuflyma® (adalimumab) and Vegzelma® (bevacizumab).

In addition, the following biopharmaceuticals have been recommended for first time listing on the PBS:

• AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for the treatment of patients with HER2-low unresectable or metastatic breast cancer, and Saphnelo® (anifrolumab) for the treatment of patients with severe systemic lupus erythematosus with high disease activity despite standard of care;
• UCB’s Bimzelx® (bimekizumab) for the treatment of severe psoriatic arthritis;
• new forms of Janssen-Cilag’s Stelara® (ustekinumab), as 45 mg and 90 mg pre-filled syringe (PFS) and pre-filled pen (PFP); and
• a new subcutaneous form and strength of Roche’s Tecentriq® (atezolizumab).

PBAC reports that applications for an Authority Script PBS listing of Regeneron’s Eylea® (aflibercept) for the treatment of patients with visual impairment due to DMO and for the treatment of visual impairment caused by CNV secondary to AMD are to be considered at a “future” PBAC meeting.

On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg dose launched in January 2024 and a 40mg dose, first approved by the FDA in May 2023, launched last year.  All dosage forms are the high concentration formulation of adalimumab (100mg/mL).

Earlier this year, Celltrion applied to the FDA seeking interchangeable status for Yuflyma®.  Celltrion has previously said that it “tentatively expects” interchangeability designation to be granted in Q4 2024.

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar),  Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab).  These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market. 

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.  

Celltrion aims to expand further into the Nordic area with plans to enter into Denmark with Remsima SC® sometime in 2024.