At its March 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted the EMA’s April 2025 “Reflection paper on a tailored clinical approach in biosimilar development”.  Stakeholders had been invited to provide comments on the draft reflection paper by 30 September 2025.  The version of the paper adopted by the CHMP can be accessed here.

As reported in April 2025, the reflection paper considers that waiving certain clinical data requirements would simplify the development and evaluation process of biosimilars while maintaining the highest standards of safety and efficacy.

According to the EMA, advances in analytical characterisation, and its extensive regulatory experience in approving significant changes in manufacturing processes of biological medicines by confirmation of structural and functional comparability, “supports the notion that under specific prerequisites, analytical comparability exercises and pharmacokinetic (PK) data can be sufficient for demonstrating biosimilarity”.

The reflection paper concludes that a tailored approach for clinical development of biosimilar candidates is possible, with Comparative Efficacy Studies no longer expected to be required for approval of biosimilars that can be “thoroughly characterised using state-of-the-art analytical methods and [which] have demonstrated similarity in physicochemical and functional properties”.  The paper expects this tailored clinical approach to be “applicable for the majority of biosimilar candidates”.

On 27 March 2026, Celltrion announced that Japan’s Ministry of Health, Labour and Welfare has approved two of its biosimilars: Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg.

According to Celltrion, Omlyclo® is the first omalizumab biosimilar approved in Japan with the full range of on‑label indications, namely bronchial asthma, idiopathic chronic urticaria, and seasonal allergic rhinitis.  The product will be offered in both prefilled syringe (PFS) and autoinjector (AI) presentation.

Omlyclo® was the first omalizumab biosimilar approved in: the EU (May 2024); Korea (June 2024, as PFS, with autoinjector approved December 2025); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status); and New Zealand (April 2025).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, Latin America’s largest pharmaceutical market.  Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development

A number of aflibercept biosimilars are approved in Japan including Alvotech/Fuji Pharma’s AVT06 (September 2025) and Sam Chun Dang’s SCD411 (September 2025).  Under a settlement and licence agreement with Regeneron & Bayer announced in January 2026, Alvotech was permitted to launch AVT06 in Japan from 1 January 2026.

On 27 March 2026, Novo Nordisk announced that the FDA has approved Awiqli® (insulin icodec-abae) injection 700 units/mL as the first and only once-weekly, long acting basal insulin for adults with type 2 diabetes.

The US approval follows the issue of a Complete Response Letter (CRL) by the FDA on 10 July 2024 regarding insulin icodec.  At the time, the CRL was said to include “requests related to the manufacturing process and the type 1 diabetes indication”.

Awiqli® was recommended for EU approval on 22 March 2024 and subsequently received EU marketing authorisation for treating diabetes in May 2024.  It has been approved in Switzerland and Canada (March 2024), Japan and Australia (June 2024) and was endorsed in China in June 2024 for type 2 diabetes.

On 27 March 2026, Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Darzalex® (daratumumab) subcutaneous (SC) formulation.  The update enables patients with multiple myeloma (or their caregivers) to administer Darzalex® from the fifth dose, if considered appropriate by their healthcare provider and following proper training.  This makes Darzalex® the first oncology injectable approved in Europe for self-administration.

J&J’s Daratumumab SC (known as Darzalex® SC in the EU and Darzalex Faspro® in the US) was first approved in the EU in 2020.  It is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze^® drug delivery technology.  Most recently, in July 2025, the European Commission approved an indication extension for Darzalex® SC as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma

The first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025.  Daratumumab biosimilars are under development by Celltrion (CT-P44), Henlius (HLX15/HLX15-SC), and CSPC.  In February 2025, Henlius announced it had entered into a licence agreement with Dr Reddy’s for commercialisation of both SC and IV formulations of HLX15, across 42 European countries and the United States.

On 25 March 2026, the Australian Pharmaceutical Benefits Assessment Committee (PBAC) published the agenda for its July 2026 meeting, with three biosimilars submitted for consideration.

One of the biosimilars will be considered for the first time, Biocon’s Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), which will be supplied by its local partner Generic Health.  Yesintek® has not yet received Australian marketing approval but has been approved in other regions, including Europe (February 2025), the US (February 2025) and Canada (October 2025).

Celltrion’s Steqeyma®, which was the first ustekinumab biosimilar to be PBS listed in August 2025, has been submitted for consideration by PBAC in new forms (Injection 45 mg in 0.5 mL vial, Injection 45 mg in 0.5 mL single use pre-filled pen, and Injection 90 mg in 1 mL single use pre-filled pen).

In addition, Celltrion has submitted four new indications for Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), being: branch retinal vein occlusion with macular oedema; central retinal vein occlusion with macular oedema; diabetic macular oedema; and subfoveal choroidal neovascularisation due to age-related macular degeneration.  Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV).  It was recommended for PBS listing in November 2025 for the same indication.

On 24 March 2026, Regeneron and Sanofi announced that the Japanese Ministry of Health, Labour and Welfare has approved Dupixent^® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP).  Dupixent® is also approved in Japan for certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD).

Regeneron and Sanofi continue to roll out new indications for Dupixent®, most recently receiving a positive recommendation by EMA’s CHMP in February 2026 for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU), and FDA approval in the same month for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) where there has been a history of sino-nasal surgery.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, and Alvotech and Advanz.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.

On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, across all reference indications.

Under a June 2022 agreement, Organon has exclusive global commercialisation rights for Henlius’ denosumab (and pertuzumab) biosimilars in Canada and other countries, “except for China; including Hong Kong, Macau and Taiwan”.  Organon expects to launch the denosumab biosimilars in Canada later in 2026.

Henlius/Organon have previously launched denosumab biosimilars in the US under the names Bildyos® and Bilprevda® (approved September 2025, launched October 2025).  Bildyos® and Bilprevda® were approved in the EU in September 2025.

Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024) were the first biosimilars approved in Canada, and were launched in August 2024.  This was followed by the Canadian approval of Celltrion’s Stoboclo® and Osenvelt® in September 2025.

On 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin® (bevacizumab), following positive results from its global Phase 3 clinical trial.  The trial was conducted in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and reportedly demonstrated clinical equivalence between Vasforda®/HD204 and Avastin®.

Under an agreement announced in July 2022, Prestige granted exclusive commercialisation rights for HD204 to Intas & Accord Healthcare for the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.  According to Prestige, in collaboration with Accord Healthcare, it has been preparing regulatory submissions for US and European markets, with marketing authorisation applications for HD204 expected to be submitted in H2 2026.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017, with Mvasi® also being approved in Europe in January 2018.  There are currently five other bevacizumab biosimilars included in the FDA’s approved drugs database: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023), and Biocon Biologics’ Jobevne™ (April 2025).  More recently, on 13 January 2026, Shanghai Henlius Biotech announced that a Biologics Licence Application (BLA) for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

On 23 March 2026, Bayer announced that Japan’s Ministry of Health, Labour and Welfare has approved Eylea™ 8 mg (aflibercept 8mg) for the treatment of macular oedema following retinal vein occlusion (RVO).  RVO is the third indication for Eylea™ 8mg in Japan, in addition to nAMD and DME (approved January 2024).

Eylea™ 8mg (‘high dose’), 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.

High dose Eylea® is approved for RVO in the US (November 2025), Europe (January 2026), the UK (February 2026) and Korea (February 2026).  It is also approved for nAMD and DME (as intravitreal injection) in those and multiple other countries, including Australia (June 2024).  Eylea™ 8mg pre-filled syringe (OcuClick™) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  Regeneron/Bayer have submitted marketing authorisation applications for Eylea™ 8mg for the RVO indication in countries including Japan (May 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea™ 8mg.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.  Alvotech has recently indicated that it expects to file the first regulatory submission for AVT29 sometime in 2026.

Biosimilars of Regeneron/Bayer’s Eylea® 2mg (aflibercept, 2mg) are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

On 23 March 2026, Cytiva announced that it has entered a contract with Yoshindo to support Yoshindo’s plans to establish biosimilar manufacturing capabilities for the Japanese market.  Yoshindo expects to begin supplying biosimilars manufactured in its own plant in Toyama from 2028.

The contract between the companies relates to Cytiva’s FlexFactory™ solution, which “integrates standardised, modular bioprocessing technologies designed to shorten the time from facility design to GMP production without deep prior expertise in single-use systems”.

Yoshindo has previously partnered with Lupin in relation to an etanercept biosimilar in Japan and launched an ustekinumab biosimilar in Japan in May 2025 in collaboration with Biocon.