On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab).  According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.  It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab).  On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step.  Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo® for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.

This follows the March 2025 CHMP recommendation for the indication.  At its March 2025 meeting, the CHMP also recommended the approval of a new Opdivo® formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).  Subcutaneous Opdivo® has previously been approved in the US (December 2024) and the UK (April 2025) for most but not all previously approved adult, solid tumour indications.

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development or in contemplation.

On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic bundling rebates, involving its anti-inflammatory drugs Enbrel® (etanercept) and Otezla® (apremilast), to convince pharmacy benefit managers (PBMs) to choose Repatha® (evolocumab) as their exclusive PCKS9 product, instead of Regeneron’s Praluent® (alirocumab).  According to Regeneron, Amgen threatened to withhold rebates unless PBMs preferred its cholesterol-lowering antibody, Repatha®, and excluded Regeneron’s Praluent®.

The jury awarded Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.  It is not yet known whether Amgen will appeal the decision.

On 18 May 2023, the US Supreme Court invalidated antibody genus claims in two Amgen patents relating to Repatha® (evolocumab).  On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid, based on lack of inventive step.  Amgen has recently had more fortune in Australia, where, on 23 April 2025, the Federal Court determined that five of Amgen’s evolocumab-related patent applications are valid and should proceed to grant.

On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils who are on a stable combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.  Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

In Singapore, Dupixent® is the first biologic medicine approved to treat these COPD patients and follows approval of the same indication in Japan in March 2025.

Dupixent® was also approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.  In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

Dupixent® was also recently approved by the US FDA for Chronic Spontaneous Urticaria (CSU) in  April 2025.  Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®, biosimilar to Alexion’s Soliris® (eculizumab), until 15 March 2027.  The decision is based on the Court’s finding that claims 1 and 2 of Alexion’s Canadian patent no. 2645810 (which encompass eculizumab) are valid and infringed by Bkemv®.

Subject to any appeal, the injunction will remain in force until 15 March 2027, the date on which Alexion’s ‘810 patent expires.  The Court also ordered Amgen to deliver up to Alexion or destroy (at Alexion’s election) all eculizumab product (including any intermediates) that would breach the injunction.

The Canadian decision comes a month after a class action complaint was filed in the US by EmblemHealth, alleging that Alexion unlawfully delayed the introduction of biosimilar competition to Soliris® by misusing its patents.  That lawsuit followed the launch of two eculizumab biosimilars in the US: Teva/Samsung Bioepis’ Epysqli® in April 2025 and Amgen’s Bkemv® in March 2025.  Both Samsung Bioepis (in September 2024) and Amgen (in May 2020) reached settlements with Alexion in relation to their US eculizumab biosimilars.

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 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg solution for infusion as monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low or HER2- ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.

The same indication was approved by the US FDA in January 2025, following the grant of priority review in October 2024.

Enhertu® has recently been considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting – the outcomes are yet to be published.  In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer.

On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows the recent EU approval of Tremfya® in April 2025 for the treatment of patients with moderately to severely active ulcerative colitis who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

In March 2025, Tremfya® was approved by the US FDA for adult patients with moderately to severely active Crohn’s disease.  Tremfya® is also approved in the US for a number of other indications, including for ulcerative colitis (September 2024) and plaque psoriasis (July 2017).

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.