On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA for unbranded Yuflyma® (adalimumab-aaty) in November 2023.

In May 2025, the FDA expanded interchangeability for Samsung Bioepis’ Hadlima® in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  In the same month, the FDA also granted Celltrion’s Yuflyma® expanded interchangeability to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  According to the companies, both biosimilars are now fully interchangeable with AbbVie’s Humira®.

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 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi.  The Fresenius patent,  EP 3 145 488 B1, claims a liquid pharmaceutical composition consisting of 50 mg/mL adalimumab, a citrate buffering system, sugar stabiliser, tonicifier and surfactant in a certain molar ratio.

In overturning a 2022 decision of the Dusseldorf Regional Court, the Higher Court granted an injunction preventing Biogen’s sales of Imraldi® in Germany and ordering Biogen to recall and destroy existing inventory and to pay damages in an amount to be determined.

An opposition to the EP ‘488 patent in the European Patent Office by Samsung Bioepis and Biogen was rejected on 20 June 2024 by the Technical Board of Appeal.

Imraldi® received European regulatory approval in 2017 and was launched in Europe in October 2018 under a licence from AbbVie entered into in April 2018.  It is known as Hadlima® in the US, where it is commercialised by Organon (approved July 2019, launched in July 2023).

Fresenius Kabi’s citrate-free adalimumab biosimilar, Idacio® was approved in Europe in 2019 and in the US in December 2022.  It was launched in Europe in 2019 and in the US in July 2023.

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 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4 mL pen) formulation in January 2025.  High concentration Hyrimoz® was first approved in Australia in May 2024 and was recommended by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in its July 2024 meeting.

There are a number of other high-concentration (100mg/mL) adalimumab biosimilars approved in Australia, including Samsung Bioepis’ Hadlima® (February 2023), Cipla/Alvotech’s Ciptunex®/Adalicip® (September 2022) and Celltrion’s Yuflyma® (March 2022).

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

• new PBS listings for enthesitis/spondylitis related JIA and chronic plaque psoriasis for paediatric patients; and
• amended PBS listings for moderate to severe ulcerative colitis and severe Crohn’s disease to allow dose escalation and more flexible dosing.

This follows PBS-listing of Sandoz’s high concentration adalimumab biosimilar, Hyrimoz®, in January 2025.

BMS’ PBS submission for Opdivo® (nivolumab) for the perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC) was not recommended.  BMS has requested a post-PBAC meeting to look for a pathway to achieve PBS-listing for this indication.

Opdivo® is currently under review by Australia’s Therapeutic Goods Administration (TGA) for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®.

Hyrimoz® (40mg/0.4mL) was approved in Australia in May 2024 and was recommended by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in its July 2024 meeting.  Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024.  Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.

In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis.  Alvotech expects a February 2025 US launch for Selarsdi®.

A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab).  There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.

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, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year.  Net sales for the first 9 months of the year were USD 7.6 billion, an increase of 9% in constant currencies compared to the same period in 2023.

Sandoz experienced strong biosimilars growth of 37% (to USD 741 million) and 32% (to USD 2.1 billion) in constant currencies (YoY) for the quarter and the year to date respectively.  This is attributed to the European launches of Pyzchiva® (ustekinumab) in July 2024 and Tyruko® (natalizumab) in January 2024, the Canadian launch of Wyost®/Jubbonti® (denosumab) in August 2024, the acquisition of Cimerli® (ranibizumab) from Coherus announced in January 2024, the uptake of Hyrimoz® (adalimumab) in the US and the continued strong demand for Sandoz’s very first biosimilar Omnitrope® (somatropin).

Key biosimilar milestones for Q3/2024 are reported to include the FDA approvals of Enzeevu^TM (aflibercept) in August 2024 and Pyzchiva® (ustekinumab) in July 2024, and the launch of the first European biosimilar to Janssen’s Stelara®, Pyzchiva® (ustekinumab), in July 2024.  Sandoz intends to launch Pyzchiva® in the US in February 2025 in the first wave of biosimilars, while the US-launch of Enzeevu™ is dependent upon factors including the outcome of ongoing BPCIA litigation.