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.

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report.  The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

The Q4 2024 edition reports that, as of September 2024, the FDA has approved 61 biosimilars across 17 unique biological molecules, 41 of which have launched in the US market.  There were four new biosimilars approved by the FDA in the last quarter: Samsung Bioepis’ Epysqli™/SB12 (Soliris®, eculizumab), Amgen’s Pavblu™/ABP 938 and Sandoz’s Enzeevu™ (Eylea®, aflibercept) and Formycon/Fresenius Kabi’s Otulfi™ (Stelara®, ustekinumab).

The report tracks the impact of US biosimilars and finds that the US adalimumab biosimilar market share reached 22% as of August 2024, largely driven by the uptake of biosimilars through private label brands.  It also reports that two tocilizumab biosimilars (vial formulation only) entered the US market in Q2 2024, Biogen/Bio-Thera’s Tofidence® and Fresenius Kabi’s Tyenne®, at Wholesale Acquisition Cost discounts of -16% (US$2,200) and -26% (US$1,960) respectively, compared to Roche’s Actemra® (US$2,656).

Samsung Bioepis cites data reporting that, from 2015-2023, total US biosimilar savings are US$36billion, with a third of those savings occurring in 2023.

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).