Following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen earlier in October 2024, Amgen confirmed during its earnings call on 30 October 2024 that it has launched Pavblu®/aflibercept (biosimilar to Regeneron/Bayer’s Eylea®) in the US and is preparing to launch Wezlana®/ustekinumab (biosimilar to Amgen’s Stelara®) and Bekemv®/eculizumab (biosimilar to Alexion’s Soliris®) in the first and second quarters of 2025 respectively.

Amgen’s Executive Vice President of Global Commercial Operations Murdo Gordon said:

“Our biosimilar products increased 9% year-over-year in the third quarter.  We have fully deployed our team in support of the recent U.S. launch of PAVBLU, a biosimilar to EYLEA. Our teams moved quickly to engage retina specialists, and we’re encouraged by the enthusiastic feedback from customers. Our teams are also ready for the upcoming U.S. launches of WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to Solaris, expected in the first and second quarters of 2025, respectively.  Overall, our biosimilars portfolio continues to deliver attractive returns driven by our efficient business model.”

On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®.  The additional presentation covers Selarsdi™ 130 mg/26 ml in a single-dose vial for intravenous infusion and expands the label to include treatment of adults with Crohn’s disease and ulcerative colitis.

This announcement follows the FDA’s previous approval in April 2024 for Selarsdi™ 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection, for both adult and paediatric use.

Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the United States, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates, including Selarsdi™.  The partnership was expanded in July 2023 to include additional products.

Selarsdi™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023 and the parties have confirmed that US launch for all indications is expected in Q1/2025.

On 11 October 2024, Meiji Seika Pharma Co., Ltd. announced that the US Food and Drug Administration (FDA) has approved its Imuldosa™ (DMB-3115, ustekinumab-srlf), biosimilar to Janssen’s Stelara® (ustekinumab).

The FDA approval follows Accord BioPharma’s announcement in January 2024 that the FDA had accepted its Biologics Licence Application (BLA) for DMB-3115.  DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas Pharmaceuticals (Accord BioPharma’s parent company) exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021.  Under the agreement, Accord BioPharma is responsible for US commercialisation.

In October 2023, Accord BioPharma reached a settlement with Janssen that allows Accord to launch DMB-3115 in the US no later than 15 May 2025.

Previously approved ustekinumab biosimilars in the US are Samsung Bioepis’ Pyzchiva®(SB17, July 2024), Alvotech/Teva’s Selarsdi™ (April 2024), Amgen’s Wezlana® (October 2023) and Formycon/Fresenius Kabi’s Otulfi® (FYB202, September 2024).

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, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA.  The European approval is for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis, while the US approval is for the same indications with the addition of ulcerative colitis.

Otulfi®/FYB202 is being commercialised in the US and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Under the agreement, Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In March 2024 Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202 in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2024”.

Ustekinumab biosimilars previously approved in Europe are Samsung Bioepis’ Eksunbi™ (September 2024), Celltrion’s SteQeyma®/CT-P47 (August 2024), Amgen’s Wezenla™ (June 2024), Sandoz/Samsung Bioepis’ Pyzchiva®/SB17 (April 2024, launched July 2024), and Alvotech/Stada’s Uzpruvo® (January 2024, launched July 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA in July 2024.

In the US, approved ustekinumab biosimilars are Samsung Bioepis’ Pyzchiva®/SB17 (July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  Further approvals and are anticipated in light of J&J/Janssen’s ustekinumab settlements with Biocon (BLA for Bmab 1200 accepted May 2024, US launch dated no later than 22 February 2025), Accord BioPharma (BLA for DMB-3115 accepted January 2024, US launch date no later than 15 May 2025) and Celltrion (application submitted with the FDA for CT-P43 in June 2023, US launch date of 7 March 2025).

On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with Janssen’s Stelara® that is manufactured using a CHO cell-line system, until the FDA has evaluated the differences in sialyation between the biosimilars and Stelara®.

The FDA will licence a biological product as “interchangeable” with a reference product if it is biosimilar and can be expected to produce the same clinical results as the reference product in any given patient.  In addition, there must be no greater risk to the patient in switching from the reference product to the proposed interchangeable version than would be involved in remaining on the reference product.

Alvotech’s Citizen Petition refers to US-approved ustekinumab biosimilars: Samsung Bioepis’ Pyzchiva® (SB17, July 2024), Alvotech/Teva’s Selarsdi™ (April 2024) and Amgen’s Wezlana® (October 2023).  The Petition claims that, like Stelara®, Selarsdi® and Wezlana® (both of which the FDA has already licensed as interchangeable ustekinumab biosimilars) are produced using a Sp2/0 host cell line or a glyco-engineered CHO cell-line system, whereas Pyzchiva® and other proposed biosimilars to Stelara® are manufactured using a CHO cell line-system, including Celltrion’s CT-P43/SteQeyma®.

If the FDA was to act on Alvotech’s submission, it would deny “interchangeability” status to Pyzchiva® and SteQeyma®, at least until it had investigated the claimed effects of differences in sialyation.

In its petition, Alvotech argues that the low sialylation of therapeutic proteins associated with CHO-based manufacturing (compared with production of monoclonal antibodies using Sp2) can significantly impact their pharmacokinetics (“PK”), particularly in terms of circulation time, immune clearance, and overall efficacy.  Alvotech claims that this means the clinical effects of CHO-derived biosimilars may be different over prolonged periods than Stelara® and those biosimilars manufactured in Sp2/0.  The Petition suggests such differences could impact dosing, efficacy, and safety profiles in ways that may not be fully captured by standard interchangeability studies.

On 5 September 2024, Cigna Group member, Evernorth, announced that it will offer biosimilar ustekinumab to US patients through its specialty pharmacy, Accredo, with no patient out-of-pocket costs.  The biosimilar offering, available beginning in early 2025, will be offered at “80% lower than the list price for Stelara” and promises to save patients around US$4,000 per year.  The interchangeable biosimilar to Janssen’s Stelara® will be produced for Evernorth’s affiliate private label distributor, Quallent Pharmaceuticals.

Evernorth made an adalimumab biosimilar available through Accredo in June 2024.  Three months later, Evernorth states that more than 25% of eligible Accredo patients are now using that biosimilar.

On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted.  BAT2206 is the first biosimilar to Janssen’s Stelara® (ustekinumab) developed by a Chinese company to be submitted to the FDA or EMA for approval.  

Bio-Thera is behind the race on this molecule, following three earlier EU approvals with Alvotech/Stada’s Uzpruvo® approved in January 2024, Samsung Bioepis’  Pyzchiva® in April 2024, and Amgen’s WezenlaTM in June 2024. On 1 July 2024, CHMP also recommended marketing authorisation for Celltrion’s Steqeyma (CT-P47, ustekinumab).  

In the US, the FDA has previously approved Samsung Bioepis’ Pyzchiva® (1 July 2024), Alvotech/Teva’s SelarsdiTM (April 2024) and Amgen’s Wezlana® (October 2023).  More approvals and launches are anticipated in the US in light of J&J/Janssen’s ustekinumab settlements with Accord BioPharma (BLA accepted January 2024, US launch date no later than 15 May 2025), Celltrion (application submitted with FDA in June 2023, US launch date of 7 March 2025) and Fresenius Kabi and Formycon (US launch date no later than 15 April 2025). 

In November 2023, Bio-Thera announced that its Phase III study of BAT2206 demonstrated it is highly similar to Stelara® in patients with moderate to severe plaque psoriasis.  

Bio-Thera’s BLA for BAT2206 is also currently under review by the China National Medicinal Product Administration.  

Bio-Thera has previously received approvals for the biosimilars QLETI® (adalimumab) in China (November 2019); TOFIDENCETM/BAT1806 (tocilizumab) in the US (September 2023, with Biogen acquiring all exclusive rights for countries other than China in a deal announced in April 2021), EU (June 2024) and China; and Avzivi®/Pobevcy® (bevacizumab,) in the US (December 2023, marketed by Sandoz) and China. 

On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report.  The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules.  Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s Selarsdi^TM (Stelara®, ustekinumab); Accord Biopharma’s Hercessi^TM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s Yesafili^TM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).

Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.

The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label.  The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  The FDA has provisionally determined Pyzchiva® as interchangeable with Stelara®. 

Samsung Bioepis is licensed to launch Pyzchiva® in the US in Q2 2025, under a  settlement and licence agreement with J&J entered into in November 2023 resolving pending US litigation between the companies. 

Samsung Bioepis’ SB17 was approved in April 2024 in  Europe (as Pyzchiva®)  and  Korea (as Epyztek™).  Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a  deal entered into in September 2023  between Sandoz and Samsung Bioepis.

A number of ustekinumab biosimilars are currently approved in Europe, including Alvotech and STADA’s Uzpruvo® (January 2024).  Amgen’s Wezenla® received a positive CHMP recommendation in April 2024.