On 20 March 2025, Johnson & Johnson (J&J) announced that the US FDA has approved Tremfya® (guselkumab) for adult patients with moderately to severely active Crohn’s disease.  According to J&J, Tremfya® is the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options.

Tremfya® is approved in the US for a number of indications, including for the treatment of adults with moderately to severely active ulcerative colitis (September 2024) and adults with plaque psoriasis (PsO) (July 2017).

In December 2024, J&J announced its submission to the FDA of two supplemental Biologics Licence Applications (sBLAs) for approval of Tremfya® for the treatment of children 6 years of age and older with moderate-to-severe PsO and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA).

On 20 March 2025, Alvotech announced its acquisition of Xbrane’s Swedish R&D operations, as well as biosimilar candidate XB003 referencing UCB’s Cimzia® (certolizumab pegol).  Xbrane will retain some pre-clinical development programs and will continue to operate as a listed company.

According to Alvotech, the deal is worth approximately USD$27M and is expected to close in April 2025, subject to approvals from the relevant authorities and Xbrane’s shareholders.

In August 2024, Xbrane commenced its out-licensing process for XB003 and in October 2024, announced that it received the first non-binding proposals on XB003.  In that announcement, Xbrane said that it had successfully scaled up the production process to clinical scale, analytical similarity to the reference product had been demonstrated, and scientific advice from EMA and FDA on the clinical development plan was expected in Q1 2025.

On 19 March 2025, the US FDA approved Merck/MSD’s Keytruda® (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-postiive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS≥1).

The Keytruda® combination first received accelerated approval for the HER2 positive Gastric/GEJ cancer indication in May 2021 based on an interim analysis of the KEYNOTE-811 trial, with the indication subsequently being revised in November 2023 to add a restriction to patients whose tumours express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.

Keytruda® (with trastuzumab and chemotherapy) was approved in Europe for the same indication in August 2023.

On 19 March 2025, Korea Biomedical Review (KBR) reported that Daewoong Pharmaceutical has launched Celltrion’s Stoboclo® (CT-P41), biosimilar to Amgen’s Prolia® (denosumab) at a 28% discount.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.

KBR also reported on 19 March 2025, that Samsung Bioepis and Hanmi Pharmaceutical have entered into a joint sales agreement for Samsung Bioepis’ SB16, biosimilar to Amgen’s Prolia® (denosumab).  Under the agreement, Samsung Bioepis will be responsible for the development and supply of the biosimilar, with both companies managing marketing and sales.

While Samsung Bioepis’ denosumab biosimilars have not yet been approved in Korea, they were approved in February 2025 in the US (Ospomyv™/Xbryk™) and Europe (Obodence™/ Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings  are ongoing.

In a joint press release on 18 March 2025, Alvotech and Dr Reddy’s announced that the US FDA has accepted their Biologic Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

According to the companies, AVT03 will be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution, as well as a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

There are three denosumab biosimilars already approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Over the past year, the FDA has accepted a number of denosumab biosimilar BLAs for review, including for: Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025.  Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.

The TGA has also updated its online list of prescription medicine registrations, with new registrations for the following expanded indications:

• MSD’s Keytruda® in combination with chemoradiotherapy for treatment of patients with high-risk locally advanced cervical cancer (FIGO 2014 Stage IB1-IIB and node-positive, or Stage III-IVA) (3 March 2025) and in combination with Astellas Pharma’s Padcev® (enfortumab vedotin) for first-line treatment of adults with locally advanced or metastatic urothelial carcinoma (24 February 2025)
• AstraZeneca’s Imfinzi® (durvalumab) as monotherapy for the treatment of adults with limited stage small cell lung cancer whose disease has not progressed following chemoradiation therapy (27 February 2025);
• Sanofi’s Dupixent® (dupilumab) for chronic obstructive pulmonary disease (25 February 2025);
• Astellas’ Padcev® (enfortumab vedotin) as monotherapy for treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed dealth-ligand-1 inhibitor (17 February 2025); and
• Bristol-Myers Squibb’s Opdivo® (nivolumab), in combination with chemotherapy, for the neoadjuvant treatment of adults with resectable non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by Opdivo® as a single agent in the adjuvant setting after surgical resection (6 February 2025).

On 14 March 2025, the US Court of Appeals for the Federal Circuit upheld the ruling of the District Court for the Northern District of Virginia refusing Regeneron’s application for a preliminary injunction preventing launch of Amgen’s Pavblu®/APB 938 (aflibercept), biosimilar to Regeneron’s Eylea®.

The Appeals Court agreed with the District Court’s September 2024 ruling that Pavblu® did not infringe the asserted claims of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.  An application to the US Appeals Court by Regeneron for an injunction preventing Amgen from launching Pavblu® pending the substantive appeal had also been rejected in October 2024.  Amgen launched Pavblu® in the US immediately following the October 2024 decision.

The Appeals Court determined that the relevant claims of the US 865 patent required an aflibercept formulation that included a separate buffer component, but Amgen’s formulation did not contain any such separate buffer.  Instead, the evidence was that “Amgen had discovered a way to prepare and formulate” aflibercept in a manner that eliminates the need for a separate buffer as the aflibercept itself provides sufficient buffering capacity to stabilise the formulation.

The litigation against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024, litigation pending).

The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the US District Court for the Northern District of Virginia to grant preliminary injunctions against Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the US 865 patent.  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  That appeal remains pending.  The aflibercept biosimilars of each of Samsung Bioepis, Formycon, Celltrion and Biocon are buffered.

Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.

On 13 March 2025, Business Wire reported that Lumicera Health Services has entered into a purchase agreement with Anda, Inc., a Teva subsidiary, for unbranded ustekinumab, biosimilar to Janssen’s Stelara®.

Under the agreement, Lumicera’s discounted net acquisition cost is estimated to generate USD$120 million in annualised savings.  These savings will be accessed immediately through Lumicera’s pass-through, acquisition cost-plus model, not delayed through a rebated model.  Plan sponsors will save between USD$112,000 and $336,000 per patient per year compared to the annual per-patient cost of the reference product.

Earlier this year, on 21 February 2025, Alvotech and Teva announced the US launch of ustekinumab biosimilar, Selarsdi® (AVT04, ustekinumab-aekn for injection).  This followed Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025.

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an agreement 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 13 March 2025, Celltrion announced that Steqeyma® (CT-P43), biosimilar to J&J’s/Janssen’s Stelara® (ustekinumab), is now available in the US for the treatment of psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis and paediatric psoriatic arthritis.

According to Celltrion, the wholesale acquisition cost (WAC) for Steqeyma® will be discounted by 85% compared with the current US WAC list price of Stelara®.

Steqeyma® received US FDA approval in December 2024 and was launched across 5 major EU countries in January 2025.

The US launch of Steqeyma® follows the US launches of Formycon/Fresenius Kabi’s Otulfi®/FYB202 (ustekinumab-aauz) in early March 2025, Sandoz/Samsung Bioepis’ Pyzchiva® (ustekinumab-ttwe) and Biocon’s Yesintek™ (ustekinumab-kfce/Bmab 1200) on 24 February 2025, Alvotech/Teva’s Selarsdi® (ustekinumab-aekn) on 21 February 2025 and Amgen’s Wezlana® (ustekinumab-auub) in early January 2025 (through Optum Health Solution’s private label subsidiary Nuvaila).

On 12 March 2025, New Zealand’s Pharmac announces that it has entered an agreement with Pfizer to fund a range of drugs from 1 April 2025, including its Besponsa® (inotuzumab ozogamicin) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL).

The agreement comes after Pharmac sought feedback on proposals to fund Besponsa® in December 2024.