Other Updates

On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab) for resectable stage IIIB to stage IV melanoma, subject to eligibility criteria.

Pembrolizumab is currently already funded in New Zealand for eligible patients with unresectable or metastatic melanoma.

There are pembrolizumab biosimilars in clinical trials for the treatment of melanoma, including Sandoz’s GME751 (Phase 1 trial in resected advanced melanoma) and Formycon’s FYB206 (Phase 1 trial commenced in June 2024 comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma).

On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients with macular oedema following retinal vein occlusion (RVO).

This comes a month after Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the same indication in April 2025.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea™ in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following RVO, and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review in April 2025.  The FDA’s target action date is 19 August 2025.

On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line with recent international guidelines.  Given regulatory agencies of major countries are moving toward waiving non-clinical studies, the revisions focus on strengthening orthogonal analytical tools and in vitro studies to establish similarity between biosimilars and their reference products.

The revisions to the guidelines include the introduction of scientific considerations and key principles for licensing biosimilars; a revised pathway for approval of biosimilars in India; the introduction of “next generation analytical methodologies” to establish analytical similarity; and new guidance on determining the need for in vivo animal studies.

India’s biosimilar guidelines were last updated in 2016.  Stakeholders have until 5 June 2025 to submit comments on the new draft in Word format to biological@cdsco.nic.in.

The publication of India’s revised draft biosimilar guidelines follow reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s 2024 guidance on biosimilar interchangeability.

On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab).  This includes the addition of Yeskintek® to the National Preferred Formulary (NPF) from 21 March 2025, Cigna’s commercial formulary from 21 March 2025, various United Healthcare formularies from 21 March 2025 and managed Medicaid from 1 March 2025.  Yesintek® is also due to be added to Medicare from 1 June 2025, CVS Health from 1 July 2025 and Optum Rx from 1 July 2025.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

In March 2025 Celltrion announced the addition of its ustekinumab biosimilar, Steqeyma® to the US Costco Member Prescription Program.  According to Samsung Bioepis’ Q1/2025 US Biosimilar Market Report, ustekinumab biosimilar entrants to the US market in 2025 have provided steep WAC discounts of over 80%.

On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations, including for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

According to an Alvotech/Teva announcement in February 2025, the FDA had granted Selarsdi® a provisional determination of interchangeability to commence after the expiry of exclusivity for Amgen’s Wezlana® (the first ustekinumab biosimilar to be approved as interchangeable in the US) on 30 April 2025.  Wezlana® and Selarsdi® are the only ustekinumab biosimilars currently approved by the FDA as interchangeable with Stelara®.

Selarsdi® was the second ustekinumab biosimilar launched in the US, in February 2025, following a settlement between Alvotech/Teva and J&J entered in June 2023, which permitted the US launch of the biosimilar from 21 February 2025.  Four other ustekinumab biosimilars have also been launched in the US to date: Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek® (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.  The partnership was expanded in July 2023 to include four additional products.

On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar.  J&J filed an appeal on 30 April 2025.  Neither the Court’s ruling on the preliminary injunction, nor the appeal filing, are publicly accessible as at 1 May 2025.

Subject to the outcome of the appeal, Samsung Bioepis is now clear to sell private label brands in the US, in addition to Pyzchiva® which Samsung Bioepis has been selling since February 2025.

J&J/Janssen commenced the US action on 24 February 2025, alleging that Samsung Bioepis had breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025.  The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claimed that Samsung Bioepis had entered into an unauthorised sublicence with a private label provider, described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM).  According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of biosimilar ustekinumab.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.  It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo® to allow administration outside of a clinical setting, such as in a person’s home, by a healthcare professional.  Phesgo® is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Earlier this month, in its 2025 first quarter earnings call, Roche described its biosimilar exposure for its Perjeta® (pertuzumab) as “relatively limited” and “not a threat that we’re super worried about right now,” considering the lack of potential competitors in late-stage development or filing.  Roche believes that the most-advanced pertuzumab biosimilar, Henlius’ HLX11, is unlikely to enter the market until at least late 2027.

HLX11 is currently under consideration for regulatory approval in the EU (March 2025), US (February 2025) and China (December 2024).  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with untreated metastatic non-squamous non-small cell lung cancer.  The decision reportedly follows communications between Sandoz and the US FDA and the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars.

According to Sandoz, it will continue its Phase 1 trial as planned.  The Phase 1 trial is investigating the pharmacokinetic similarity and efficacy, safety, and immunogenicity of Sandoz’s pembrolizumab biosimilar, GME751, compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

This follows a similar announcement by Formycon in February 2025 regarding the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®.  According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206.  Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab).  The SC formulation of nivolumab can be given as a 3–5 minute injection instead of the 30 or 60 minute intravenous (IV) infusion.

Amgen currently has a nivolumab biosimilar under development, having enrolled patients in a Phase 3 study evaluating the efficacy, safety, and immunogenicity of Amgen’s ABP 206 compared with Opdivo®.  The study is expected to be completed in 2027.

Sandoz is also developing a biosimilar of nivolumab and is recruiting patients for an integrated Phase I/III trial in the advanced melanoma setting.

On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they have entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab).

Under the agreement, Henlius will develop and manufacture the biosimilar, HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan and Australia.  Henlius will receive an upfront payment of USD 31 million, and up to USD 270 million in milestone payments.

Ipilimumab is approved in combination with nivolumab (BMS’ Opdivo®) for metastatic melanoma and other cancers.  The Henlius deal will therefore complement Sandoz’s development of its own biosimilar to nivolumab, in relation to which Sandoz is recruiting patients for an integrated Phase I/III trial in the advanced melanoma setting.