On 4 August 2025, Celltrion announced that, according to market research firm IQVIA, Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), reached 24% market share in Europe in Q1 2025, up 3% on the previous quarter and now only one percentage point behind the leading product.

Celltrion stated that this is a “significant achievement” given that Yuflyma® joined the top prescription tier three years later than its competitors and in a “highly competitive market with over 10 adalimumab products”, including originator product Humira®.

In April 2025, Celltrion announced that it secured interchangeability designation in the US for its high concentration (100mg/mL) citrate free presentation of Yuflyma®.  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 9 July 2025, the Amsterdam District Court ruled that the Pharmaceutical Accountability Foundation (PAF) lacked standing in its collective claim against AbbVie regarding the sale of Humira® (adalimumab) in the Netherlands, finding that PAF did not hold the requisite interest in the claim.

PAF commenced proceedings against AbbVie in February 2023, alleging that AbbVie acted unlawfully by overcharging for Humira®, leading to the displacement of publicly insured health services and violating fundamental human rights under Article 2 of the European Convention on Human Rights, and further breached relevant competition laws by abusing its market power.

In a statement released on 9 July 2025, PAF says that it had estimated that AbbVie “earned as much as €1 billion in excess profit in the Netherlands, costing the health system an equivalent of 13,950 years of healthy life”, and that it was “disappointed that the court did not address the merits of [the] case”.  PAF is considering an appeal.

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 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.