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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Biocon Joins Alvotech in Filing US PGR Challenging Regeneron’s High Dose Aflibercept Patent

Apr 2, 2026

On 2 April 2026, Biocon filed a petition for post grant review (PGR) of Regeneron’s patent US12168036 entitled “Methods for Treating Angiogenic Eye Disorders with High Doses of VEGF Receptor Fusion Proteins”.

Biocon’s petition seeks to join Alvotech’s pending PGR in relation to the same patent. Alvotech’s PGR petition was filed on 17 September 2025 and the PGR was instituted by the Patent Trial and Appeal Board on 3 March 2026. Biocon’s PGR petition is substantially the same as that filed by Alvotech.

Regeneron’s ‘036 patent relates to methods for treating an angiogenic eye disorder by intravitreal administration of about 100 microlitres or less of at least about 8mg of a VEGF receptor fusion protein in a formulation with a particular viscosity. Both Biocon’s and Alvotech’s PGR petitions argue that the claims of the ‘036 patent are invalid for obviousness and lack of written description.

High dose Eylea® is approved in the US (as Eylea HD®) for wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy (August 2023) and retinal vein occlusion (November 2025). It is also approved in other jurisdictions (as Eylea™ 8mg), including Europe (January 2026), the UK (February 2026) and Korea (February 2026). Eylea™ 8mg pre-filled syringe (OcuClick™) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea HD®. 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.

Biocon has not yet announced that it has a high dose Eylea® biosimilar in development. Biocon’s Yesafili™ was one of the first approved interchangeable aflibercept (2 mg) biosimilars in the US in May 2024. Biocon and Regeneron settled US BPCIA litigation regarding aflibercept (2 mg) in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026, or earlier under certain undisclosed circumstances.

New Indication Alert: MSD’s Keytruda® Approved in EU for Ovarian Cancer

Apr 2, 2026

On 2 April 2026, MSD announced that the European Commission has approved Keytruda® (pembrolizumab) in combination with paclitaxel, with or without bevacizumab, for the treatment of platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PDL1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.

The EC approval follows a CHMP positive opinion in February 2026 for the indication, which was also approved by the FDA in February 2026 in both IV (Keytruda®) and subcutaneous (Keytruda Qlex™) formulations.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025). Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.

Bayer Reduces Eylea® Price in India by 44%

Apr 2, 2026

On 2 April 2026, The Economic Times reported that Bayer has reduced the upfront cost of Eylea® (aflibercept, 2mg) in India by about 44% to expand the eligible patient pool. According to the report, Eylea® will now be priced at Rs 29,998, down from Rs 53,141.

The announcement comes just under 2 months after Zydus’s Indian launch of its aflibercept biosimilar, Anyra™. Anyra™ is the first aflibercept 2mg biosimilar developed in India and was launched under licence from Regeneron and Bayer.

There is at least one other aflibercept biosimilar set to launch in India in 2026. In September 2025, Biocon’s Yesafili® was recommended by India’s Subject Expert Committee (SEC). This recommendation was subject to Biocon submitting a Phase IV clinical trial protocol to the Central Drugs Standard Control Organisation within 3 months of obtaining the marketing authorisation grant. In January 2026, Biocon reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® in Europe and ROW, which permits Biocon to commercialise Yesafili® in India (and ROW other than UK, US and Canada) in H2 2026.

Eylea® was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

FDA Approves Extended Dosing Interval for Regeneron/Bayer’s Eylea HD®

Apr 2, 2026

On 2 April 2026, Regeneron announced that the FDA has approved an extended dosing interval for Eylea HD® (aflibercept 8mg, “high dose”) of up to every 20 weeks for patients with nAMD and diabetic macular oedema (DME), following one year of successful response based on visual and anatomic outcomes. The new dosing regimen means that nAMD/DME patients can be treated as little as 2-3 times a year.

The approval of the extended dosing regimen is based on 96 week data from the PHOTON and PULSAR trials. It follows FDA approval of Eylea® HD in November 2025 for RVO with up to 8 weekly dosing after an initial monthly dosing period, and a 4-weekly dosing option for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).

Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® has an FDA target action date in April 2026. The BLA had been on hold while Regeneron sought to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA. Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA. Regeneron had planned to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.

Eylea HD® (known as Eylea™ 8mg in other jurisdictions), 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).

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® (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® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

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.

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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.

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Xbrane Delays US Ranibizumab Biosimilar BLA Resubmission to April/May 2026

Mar 31, 2026

On 31 March 2026, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025. In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026. However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans have now been delayed to April/May 2026.

According to Xbrane, following resubmission of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in October/November 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US. The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022) and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®. It was launched in the EU in April 2023.

Henlius/Organon Settle US Denosumab Litigation with Amgen

Mar 31, 2026

Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as recorded by a Consent Order and Judgment filed with the US District Court for the District of New Jersey on 31 March 2026. Henlius/Organon consented to an order that 26 US patents asserted by Amgen (relating to Amgen’s Prolia®/Xgeva® (denosumab)) are valid and infringed by making, using, selling or offering to sell Henlius/Organon’s denosumab biosimilars in the US, or importing them into the US.

There has been no announcement by the parties in relation to the settlement and whether a US launch date for Bilprevda® and Bildyos® has been agreed. Samsung Bioepis’ Q1 2026 Biosimilar Market Report had indicated the products had launched in the US in October 2025.

Bildyos® and Bilprevda® were approved in the US in September 2025. Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

The BPCIA litigation against Henlius/Organon was one of a number of US proceedings brought by Amgen in relation to biosimilar denosumab, many of which have now settled. Amgen has entered into US denosumab litigation settlements with Sandoz (settlement in April 2024, Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (March 2025 settlement, Conexxence® and Bomyntra® launched early July 2025); Celltrion (settlement in January 2025, Stoboclo® and Osenvelt® launched July 2025, following January 2025 settlement); Accord/Intas (settlement in July 2025, FDA approval of Osvyrti® and Jubereq® in November 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025 following settlement shortly after commencement of proceedings in June 2025); Samsung Bioepis (settlement in September 2025, Ospomyv® included on US formularies from 1 April 2026); and Gedeon Richter/Hikma (settlement in November 2025, Enoby™ and Xtrenbo™ launched in January 2026).

Amgen still has pending US denosumab litigation against Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).

Bio-Thera/Gedeon Richter’s Biosimilar Ustekinumab Launched in Europe

Mar 30, 2026

In a LinkedIn post on 30 March 2026, Gedeon Richter announced that it expects its ustekinumab biosimilar “to become progressively available across European markets starting from March 2026”.

Gedeon Richter is commercialising the ustekinumab biosimilar in Europe under a licence and commercialisation agreement entered into with Bio-Thera in October 2024. Under the agreement, Bio-Thera is responsible for the development and manufacture of BAT2206 (ustekinumab), while Richter has commercialisation rights for the EU, UK and Switzerland.

BAT2206 was approved in the EU in August 2025 (as Usymro®), following a positive CHMP opinion in June 2025.

There are a number of ustekinumab biosimilars now marketed in the EU, including STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® (both launched in July 2024) and Celltrion’s Steqeyma® (launched November 2024). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

Celltrion Launches High Dose (300 mg) Biosimilar Omalizumab in Korea

Mar 30, 2026

On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.

The Korean launch follows the January 2026 Canadian approval of high dose Omlyclo® (PFS and autoinjector) and approvals of a PFS presentation of the 300 mg dosage form in the US in December 2025 and EU in November 2025.

Celltrion is actively marketing Omlyclo® around the world, with a “launch event” held in Brazil on 31 March 2026, at which Celltrion and “key opinion leaders” presented clinical data, global prescribing experience and “value for use in clinical settings” in relation to the biosimilar. Omlyclo® was launched in Brazil in November 2025 and secured a state government tender in Santa Catarina.

While Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world, at least Aurobindo, Teva, Glenmark and Kashiv have omalizumab biosimilars under development. On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

Teva’s Biosimilar Denosumab FDA-Approved & Biosimilar Omalizumab Applications Accepted for Review in US & EU

Mar 30, 2026

On 30 March 2026, Teva Pharmaceutical Industries announced that the FDA has approved Ponlimsi™, biosimilar to Amgen’s Prolia® (denosumab). At the same time, Teva also announced that its regulatory applications for a biosimilar to Genentech/Novartis’ Xolair® (omalizumab) have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications.

Ponlimsi® was approved in the EU in November 2025, together with Teva’s biosimilar to Amgen’s Xgeva® (denosumab), Degevma®. The US has a highly competitive denosumab biosimilar market with a number of denosumab biosimilars already launched, including Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, launched January 2026).

Teva’s omalizumab biosimilars are behind Celltrion’s Omlyclo® (omalizumab), which has already been approved in the EU (May 2024; high dose (300mg) form approved November 2025) and the US (March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose). 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. Aurobindo, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.

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.

New Indication Alert: AZ/Daiichi Sankyo’s Enhertu® + THP Conditionally Approved in China for HER2-Positive Breast Cancer

Mar 27, 2026

On 27 March 2026, Daiichi Sankyo announced the conditional approval in China of Enhertu® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) for the neoadjuvant treatment of HER2 positive stage 2 or 3 breast cancer. According to Daiichi Sankyo, this is the first approval for Enhertu® globally for neoadjuvant treatment of HER2 positive early stage breast cancer.

The conditional approval is based on Phase III results from the DESTINY-Breast 11 trial, which demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response rate by administering Enhertu® followed by THP. Confirmation of long-term clinical benefit in patients with early or locally advanced breast cancer is required for full approval.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.

Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.

Path Cleared for Sandoz’s Biosimilar Aflibercept in Germany After Regeneron/Bayer Withdraw PI Application

Mar 27, 2026

Regeneron and Bayer have withdrawn a preliminary injunction (PI) application against Sandoz in Germany in relation to Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg). According to a JUVE Patent report of 27 March 2026, the result is that Sandoz and its German subsidiary, Hexal, are now free to market Afqlir® in Germany.

The withdrawal of the PI application follows a February 2026 decision of the Munich Higher Regional Court to provisionally suspend enforcement of a first instance judgment. That first instance judgment, issued in January 2026, had granted Regeneron and Bayer a preliminary injunction preventing Hexal/Sandoz from marketing their aflibercept biosimilar in Germany. In a March 2026 interim order, the Court also cited the lack of any urgency in relation to the PI.

Sandoz’s Afqlir® was EU-approved in November 2024 and was launched in the UK in November 2025. At the time of the UK launch, Sandoz announced that launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026.

German Courts have issued PIs in relation to a number of aflibercept biosimilars. At the same time as granting the PI against Sandoz in January 2026, the Munich Regional Court granted PIs against STADA, Celltrion and Advanz Pharma. While the PIs against STADA, Hexal/Sandoz and Celltrion were limited to Germany, the PI against Advanz covered 21 countries. A PI (September 2025), and subsequent permanent cross-border injunction (October 2025) were also granted preventing Formycon from launching its aflibercept biosimilar, FBY203 (Baiama®/Ahzantive®), in multiple European countries.

Since that time a number of EU settlements have been reached in relation to aflibercept biosimilars. Samsung Bioepis reached a settlement and licence with Regeneron/Bayer in January 2026, permitting it to launch SB15 (Opuviz®) in the UK from January 2026 and in the EU from April 2026. Alvotech’s commercialisation partners, Advanz Pharma (EU/UK) and STADA (Germany) are also permitted to launch AVT06/Mynzepli®/Afiveg® (aflibercept) in the EU from May 2026, following a settlement announced in January 2026. In March 2026, Formycon and Klinge announced they had entered a settlement agreement with Regeneron/Bayer permitting launch of their aflibercept biosimilar, FYB203 (Baiama®/Ahzantive®), in Europe, and key regions in APAC and LATAM from May 2026. According to Celltrion, it is “actively pursuing patent agreements” with Regeneron/Bayer in relation to aflibercept, including in Germany.

In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Mynzepli® (AVT06) (aflibercept). This ruling cleared the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1 183 353 (encompassing aflibercept) on 23 November 2025.

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.

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New Indication Alert: Dupixent® (Dupilumab) First Targeted Medicine for Adults with Bullous Pemphigoid (BP)

Mar 24, 2026

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.

Henlius/Organon’s Denosumab Biosimilars Approved in Canada

Mar 24, 2026

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.

Prestige Biopharma & Intas/Accord Healthcare Prepare for Biosimilar Bevacizumab Commercialisation in US/EU

Mar 24, 2026

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.

New Indication Alert: Regeneron/Bayer’s Eylea™ 8 mg Approved in Japan for RVO

Mar 23, 2026

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.

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).

Yoshindo Strengthens Plans to Establish Biosimilar Manufacturing Capabilities in Japan with Cytiva Contract

Mar 23, 2026

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.

Gedeon Richter/Mochida’s Biosimilar Tocilizumab Approved in Japan

Mar 23, 2026

On 23 March 2026, Mochida Pharmaceutical and Ayumi Pharmaceutical announced that RGB-19, biosimilar to Roche’s RoActemra® (tocilizumab) was approved in Japan. The approval covers forms of the biosimilar for intravenous infusion, subcutaneous injection and in an autoinjector.

RGB-19 was co-developed by Mochida and Gedeon Richter, with Mochida filing marketing authorisation applications for RGB-19 in Japan, and Richter doing so in major global markets outside Japan. Under a collaboration agreement between Mochida and Ayumi in relation to commercialisation of RGB-19 in Japan, Mochida is responsible for supplying the product to Ayumi, which is in turn responsible for sales in the country.

RGB-19 received a positive CHMP opinion in Europe in February 2026 under the brand name Tuyory®. This followed Gedeon Richter’s announcement of positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19 in January 2025, both of which met their primary endpoints.

The first tocilizumab biosimilar approved in Japan was Celltrion’s Avtozma®/CT-P47, in September 2025. Avtozma® has also been granted marketing authorisation in a number of other regions, including the US (January 2025) and EU (February 2025), following approval of Biogen/Bio-Thera’s Tofidence®/BAT1806 (US: September 2023, EU: June 2024) and Fresenius Kabi’s Tyenne® (US: March 2024, EU: November 2023). Avtozma® was the first tocilizumab biosimilar approved in Australia (May 2025), and New Zealand (December 2025).