Pearce IP BioBlast® for the week ending 27 March 2026

Mar 31, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 27 March 2026 are set out below:

Aflibercept

23 March 2026 | JP | New Indication Alert: Regeneron/Bayer’s Eylea™ 8 mg Approved in Japan for RVO

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… Read more here.

Bevacizumab

24 March 2026 | US | EU | Prestige Biopharma & Intas/Accord Healthcare Prepare for Biosimilar Bevacizumab Commercialisation in US/EU

On 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin®… Read more here.

Denosumab

24 March 2026 | CA | Henlius/Organon’s Denosumab Biosimilars Approved in Canada

On 24 March 2026, Shanghai Henlius Biotech announced that Health Canada has approved Bildyos® and Tuzemty® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.

Daratumumab

27 March 2026 | EU | J&J’s Darzalex® (Daratumumab) First EU Approved Oncology Injectable for Self-Administration

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… Read more here.

Dupilumab

24 March 2026 | JP | New Indication Alert: Dupixent® (Dupilumab) First Targeted Medicine for Adults with Bullous Pemphigoid (BP)

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… Read more here.

Golimumab

23 March 2026 | IN | Bio-Thera & Intas Partner to Supply Biosimilar Golimumab in India

On 23 March 2026, Bio-Thera Solutions announced that it has entered an exclusive agreement with Intas Pharmaceuticals for the Indian commercialisation of BAT2506 (golimumab)… Read more here.

Insulin icodec

27 March 2026 | US | Novo Nordisk’s Once Weekly Insulin, Awiqli®, Approved in US

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… Read more here.

Omalizumab, Aflibercept

27 March 2026 | JP | Celltrion’s Omalizumab & Aflibercept Biosimilars Approved in Japan

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’… Read more here.

Tocilizumab

23 March 2026 | JP | Gedeon Richter/Mochida’s Biosimilar Tocilizumab Approved in Japan

On 23 March 2026, Mochida Pharmaceutical and Ayumi Pharmaceutical announced that RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab) was approved in Japan… Read more here.

Ustekinumab, Aflibercept

25 March 2026 | AU | Ustekinumab & Aflibercept Biosimilars on the July 2026 PBAC Agenda

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

Biopharma Deals

23 March 2026 | JP | Yoshindo Strengthens Plans to Establish Biosimilar Manufacturing Capabilities in Japan with Cytiva Contract

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… Read more here.

Biopharma News

27 March 2026 | EU | CHMP Adopts EMA’s Reflection Paper on Streamlining Biosimilar Development

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… Read more here.

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees). Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice. Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”. Ranked in Chambers Asia Pacific, Chambers Global, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.

Pearce IP is the premier life sciences focussed firm in ANZ. Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees). In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

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Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®. She is currently completing her Juris Doctor at the University of Sydney. With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’. Maliha is interested in the intersection of law and science, and digital transformation. She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

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CHMP Adopts EMA’s Reflection Paper on Streamlining Biosimilar Development

Mar 27, 2026

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”.

Celltrion’s Omalizumab & Aflibercept Biosimilars Approved in Japan

Mar 27, 2026

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.

Novo Nordisk’s Once Weekly Insulin, Awiqli®, Approved in US

Mar 27, 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.

J&J’s Darzalex® (Daratumumab) First EU Approved Oncology Injectable for Self-Administration

Mar 27, 2026

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.

Ustekinumab & Aflibercept Biosimilars on the July 2026 PBAC Agenda

Mar 25, 2026

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.

Pearce IP BioBlast® for the week ending 20 March 2026

Mar 24, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 March 2026 are set out below:

Aflibercept

19 March 2026 | EU | LATAM | APAC | EU, LATAM & APAC Launches of Formycon/Klinge’s Biosimilar Aflibercept Planned From May 2026 Following Regeneron/Bayer Settlement

On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s… Read more here.

13 March 2026 | TW | US | Regeneron Seeks US Discovery for Patent Litigation in Taiwan Regarding Sam Chun Dang’s Biosimilar Aflibercept

On 13 March 2026, IAM reported that Regeneron has applied to a US Court to seek discovery of manufacturing-related documents from Sam Chun Dang’s US subsidiaries for use in… Read more here.

Etanercept

13 March 2026 | US | Sandoz Appeals US Court’s Dismissal of Antitrust Claim Against Amgen Relating to Biosimilar Etanercept

On 13 March 2026, Sandoz filed an appeal with the US Court of Appeals for the Fourth Circuit, challenging the dismissal of the antitrust proceeding it had commenced in April… Read more here.

Evolocumab, Arilocumab

12 March 2026 | Sanofi/Regeneron & Amgen Settle Dispute Over PCSK9 Inhibitors, Praluent® & Repatha®

On 12 March 2026, Juve Patent reported that Sanofi/Regeneron and Amgen “have apparently settled” their dispute over PCSK9 inhibitors Praluent® (arilocumab) and Repatha®… Read more here.

Golimumab, Aflibercept, Vedolizumab, Pembrolizumab

19 March 2026 | Alvotech Provides Updates on Launch & Regulatory Plans for Golimumab, High Dose Aflibercept, Vedolizumab and Pembrolizumab Biosimilars

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab… Read more here.

Nivolumab

20 March 2026 | US | EU | CN | BMS’ Opdivo® Combos Approved in US & EU for cHL Indications, while Henlius’ Biosimilar Nivolumab IND Application Approved in China

On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the… Read more here.

Ranibizumab

19 March 2026 | JP | Chugai Files Regulatory Application in Japan for Ocular Implant Component of Ranibizumab Port Delivery Platform

On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical… Read more here.

Semaglutide

21 March 2026 | IN | Generic Semaglutide Launches in India, including by Dr Reddy’s, Zydus, Alkem, Sun Pharma & Glenmark

On 21 March 2026, multiple generic semaglutide products launched on the Indian market, proclaiming “Day 1 entry” on expiry of Novo Nordisk’s core Indian patent for semaglutide… Read more here.

20 March 2026 | US | Novo Nordisk’s Wegovy® HD (Semaglutide 7.2mg) Receives FDA Approval

On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance… Read more here.

16 March 2026 | Samsung Bioepis & G2GBIO Ink Deal for Development of Long-Acting Semaglutide

On 16 March 2026, Samsung Bioepis and its sister company, Epis NexLab, announced they have entered into a research collaboration and licence agreement with G2GBIO to … Read more here.

Tocilizumab

17 March 2026 | US | Celltrion’s Tocilizumab Biosimilar SC Formulation Launched in US

On 17 March 2026, Celltrion announced that the subcutaneous (SC) formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), is now available in the US… Read more here.

Ustekinumab

20 March 2026 | CA | Health Canada Approves Celltrion’s Autoinjector Formulation of Biosimilar Ustekinumab

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s… Read more here.

Vedolizumab

18 March 2026 | Sandoz & Samsung Bioepis Partner on 5 Biosimilars Including Vedolizumab

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars… Read more here.

Biopharma News

10 March 2026 | Sandoz Announces New Biosimilar Development, Manufacturing and Supply Unit

On 10 March 2026, Sandoz announced the creation of a new global biosimilar development, manufacturing and supply unit, which will come into effect on 1 April 2026… Read more here.