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).

On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

The first set of data is results from a Phase 3 study comparing the efficacy, safety, immunogenicity, and pharmacokinetics of Biocon’s Bmab 1200 (bUstekinumab), with Janssen’s Stelara® (ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis.  The results are said to show biosimilarity between Bmab 1200 and Stelara®.

In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.  In February 2024, Biocon entered a settlement agreement with Janssen enabling it to launch Bmab 1200 in the US in February 2025.  A second patent settlement and licence agreement was entered between Biocon and Janssen in August 2024, allowing Biocon to commercialise Bmab 1200 in Europe, the UK, Canada and Japan.  Biocon has submitted regulatory applications in each of these jurisdictions.

The second set of data is results from a Phase 3 study evaluating repeated switches between Biocon’s Hulio® (adalimumab-fkhp, 40mg/0.8ml) and AbbVie’s high-concentration Humira® (adalimumab, 40mg/0.4ml) in patients with moderate to severe chronic plaque psoriasis.  This data reportedly shows interchangeability between the two products.  Biocon says it has submitted the data to the FDA to support an interchangeable designation for its adalimumab biosimilar.

Biocon’s Hulio® (adalimumab-fkhp) was first approved in Europe in 2018 and in the US in 2020.

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).

On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes.

This comes three years after Abrilada was first recommended for listing in July 2021 by Australia’s Pharmaceutical Benefits Advisory Council, with required documentation having not been submitted by Pfizer until February this year.  Abrilada® was first approved by the TGA in March 2021 for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis.

There are 8 biosimilars to AbbVie’s Humira® approved in Australia: Amgen’s Amgevita® (approved in November 2017, PBS listed in April 2021); Samsung Bioepis’ Hadlima® (approved in January 2018, PBS listed in April 2021), Sandoz’s Hyrimoz® (approved in March 2019, PBS listed in April 2021), Pfizer’s Abrilada® (approved in March 2021, PBS listed in August 2024), Mylan’s Hulio® (approved in May 2021, Mylan not proceeding to PBS listing), Celltrion’s Yuflyma® (approved in March 2022, PBS listed in March 2023, and Cipla’s Adalicip®/Ciptunec® (approved in September 2022, PBS listed in January 2024).

In August 2024, Fresenius Kabi withdrew its adalimumab biosimilar, Idacio®, from the AU market citing “commercial reasons/commercial viability”.

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

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

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.