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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.

Pearce IP Appoints Peter O’Sullivan as Executive, Deputy CEO & Head of People and Culture

Pearce IP is pleased to announce the appointment of Peter O’Sullivan as Executive, Deputy CEO & Head of People and Culture.

Peter is an experienced C-suite professional services executive, and joins Pearce IP with more than 30 years’ experience spanning human resources, business, and law.  He holds an MBA, BA and LLB (Hons), is a Graduate Member of the Australian Institute of Company Directors (AICD), and has completed the Harvard Business School Global Executive Leadership Program.

Peter is Deputy CEO across ANZ and will oversee finance, operations, marketing, and human resources.  He will work closely with leadership and teams across the firm to support Pearce IP’s continued growth and strategic objectives.

Most recently, Peter spent 14 years at BDO, where, as Chief People Officer he played a significant role in people, culture, leadership, and organisational strategy during a period of substantial and sustained business growth.  His contribution as an executive leader at BDO was recognised with his appointment to the firm’s Partnership in 2024.

Peter began his career as a commercial litigator at major law firm Blake Dawson Waldron (now Ashurst), before transitioning into senior human resources and executive leadership roles.  His career has included senior human resources roles at Blake Dawson Waldron, the Queensland Department of Emergency Services, SPARQ Solutions, and Bankwest, and non-executive director roles with the Queensland Doctors’ Health Programme and Metro Arts.

Founder and CEO Naomi Pearce said the appointment reflects the next stage of Pearce IP’s evolution.

“Peter is a seasoned leader with qualifications and more than 30 years’ experience in HR, law and business, and I am delighted that he has joined Pearce IP.  As we approach delivery against our 2027 Vision, I am excited to work with Peter as we continue to set the standard for excellence in the provision of legal and IP services.”

Peter said:

“I’m delighted to be joining Pearce IP at such an exciting stage in its journey.  The firm has built a strong culture and reputation, and I look forward to working with Naomi and the team to support continued growth and deliver on Pearce IP’s long-term vision.  I believe great businesses are built on great people, and I’m excited to help strengthen the leadership, culture and operational capability that will underpin the next chapter.”

Peter’s appointment forms part of Pearce IP’s leadership investment as the firm continues delivering against its 2027 Vision and begins shaping its 2037 Vision.


 

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

 

Pearce IP BioBlast® for the week ending 12 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 12 June 2026 are set out below:


Aflibercept

On 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg)… Read more here.

Daratumumab

On 11 June 2026, Xbrane Biopharma and JOINN Biologics US announced that they have entered into a strategic partnership to develop Xbrane’s Xdarzane™, biosimilar… Read more here.

Denosumab

On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating… Read more here.

 

On 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe)… Read more here.

Nivolumab

On 11 June 2026, Ono Pharma announced that it submitted a supplemental application for Opdivo® Intravenous Infusion (nivolumab) in Japan, to expand its use for the… Read more here.

Pembrolizumab

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in… Read more here.

Semaglutide

On 10 June 2026, Gedeon Richter and Indian-headquartered Hetero Labs announced that they have entered a global collaboration agreement to jointly develop, register… Read more here.

Serplulimub

On 9 June 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved a new indication of Hansizhuang® (serplulimab… Read more here.

Tocilizumab

On 10 June 2026, Organon announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Tofidence® (IV), biosimilar to Genentech’s… Read more here.

Trastuzumab emtansine

On 10 June 2026, GxP News reported that Biocad has commenced patient enrolment for a phase 3 clinical trial of BCD-237 (trastuzumab emtansine), biosimilar to Genentech’s… Read more here.

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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

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 LawExecutive 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 1000IAM 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.

Chantal Savage

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

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.

FDA Approves MSD’s Pembrolizumab/ Belzutifan Combo for Kidney Cancer

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with MSD’s Welireg® (belzutifan) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The FDA reviewed the combination under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada.  The application reviews are ongoing at the other regulatory agencies.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region,  and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

Amgen’s High Dose (8 mg) Aflibercept Biosimilar in Ph 3 Trial

On 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg).

The clinical trial was commenced in May 2026 and aims to demonstrate similarity in efficacy between ABP 938 8 mg and US-sourced Eylea HD® by evaluating the change in best corrected visual acuity in patients with nAMD.  The trial is being conducted across 18 locations in the US and has an estimated completion date of January 2028.

Eylea HD® (‘high dose’), known as Eylea® 8 mg outside the US, was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

8 mg Eylea® has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023).  It is also approved for the treatment of patients with macular oedema following retinal vein occlusion (RVO) including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).

Alvotech is developing a high dose aflibercept biosimilar, AVT29.  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 2 mg) in the US.  Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.

Ono Seeks Approval of Nivolumab in Japan for Unresectable Anaplastic Thyroid Cancer

On 11 June 2026, Ono Pharma announced that it submitted a supplemental application for Opdivo® Intravenous Infusion (nivolumab) in Japan, to expand its use for the treatment of unresectable anaplastic thyroid cancer.

Ono first launched Opdivo® in Japan in September 2014 for the treatment of unresectable malignant melanoma.  More recently, Opdivo® was approved in Japan in combination with Yervoy® (ipilimumab) for unresectable hepatocellular carcinoma (June 2025).

Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.

Xbrane and JOINN Biologics Partner on Daratumumab Biosimilar Development

On 11 June 2026, Xbrane Biopharma and JOINN Biologics US announced that they have entered into a strategic partnership to develop Xbrane’s Xdarzane™, biosimilar to J&J’s Darzalex® (daratumumab).

Under the agreement, US-based Contract Development & Manufacturing Organisation (CDMO), JOINN Biologics, will provide “customised process development” of the Xbrane biosimilar and will be responsible for further pilot scale process development to demonstrate analytical similarity of Xdarzane™ to Darzalex® and deliver a commercially viable process yield.  Xbrane will be responsible for global out-licensing activities to commercial partners.  Subsequent development steps will then be conducted by Xbrane and JOINN, including scale-up, clinical development, regulatory filing and commercial manufacturing.

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.  Henlius dosed its first patient in a phase 1 clinical trial of HLX15-SC (daratumumab SC) in May 2026.

Pearce IP BioBlast® for the week ending 5 June 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 5 June 2026 are set out below:


Aflibercept, Golimumab

On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and… Read more here.

Canakinumab

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab)… Read more here.

Dupilumab

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation… Read more here.

Nivolumab

On 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD)… Read more here.

Omalizumab

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to… Read more here.

 

On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US… Read more here.

Pembrolizumab

On 5 June 2026, Shanghai Henlius Biotech announced that the first US patient has been dosed in its international Phase 1 clinical trial of HLX17, biosimilar to MSD’s… Read more here.

Ranibizumab

On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial… Read more here.

Vedolizumab

On 8 June 2026, Alvotech announced that its Biologics License Application (BLA) for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), has been accepted for review by… Read more here.

Vusolimogene oderparepvec

On 29 May 2026, Replimune announced that, following collaborative communications with the FDA, the company and the FDA have aligned on a path for resubmission and… Read more here.

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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

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 LawExecutive 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 1000IAM 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.

Chantal Savage

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

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.

Biocad Commences Patient Enrolment for Ph 3 Biosimilar Trastuzumab Emtansine Trial

On 10 June 2026, GxP News reported that Biocad has commenced patient enrolment for a phase 3 clinical trial of BCD-237 (trastuzumab emtansine), biosimilar to Genentech’s Kadcyla®, for treatment of locally advanced unresectable or metastatic HER2 positive breast cancer.

The phase 3 trial is being conducted in 48 clinical centres in Russia and is expected to be completed by the end of 2031.  The study will assess the efficacy, safety and immunogenicity profiles for BCD-237 against Kadcyla® following repeated intravenous administration.

Kadcyla® was first approved in the US in February 2013 and is now approved in over 100 countries.  The first reported Kadcyla® biosimilar was Zydus’ Ujvira®, which was launched in India in May 2021.  Trastuzumab emtansine biosimilars are also in development by Formosa Pharmaceuticals (TSY-110, co-developed with EirGenix), which is aiming to become the first to have a Kadcyla® biosimilar launched in regulated markets like the US and EU. with clinical trials expected to commence in 2026, and Zhejiang Hisun Pharmaceutical (HS630), which reported results of a nonclinical study of the biosimilar in 2025.

New Indication Alert: Organon’s Biosimilar Tocilizumab FDA-Approved for CAR-T-Induced CRS & COVID 19 Patients

On 10 June 2026, Organon announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Tofidence® (IV), biosimilar to Genentech’s Actemra® (tocilizumab), expanding the indications to include (a) treatment of patients 2 years and older with CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS) and (b) hospitalised adult and paediatric patients aged 2 years and older with COVID-19 who are receiving corticosteroids and require supplemental oxygen, ventilation or extracorporeal membrane oxygenation (ECMO).

Organon acquired the US regulatory and commercial rights to Tofidence® (BAT1806) from Biogen in April 2025.  Bio-Thera Solutions, the product developer, retains the manufacturing rights for Tofidence® for the US market.

Tofidence® (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023launched May 2024) for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  This approval was followed by Fresenius Kabi’s Tyenne® (SC formulation approved March 2024IV formulation launched April 2024SC formulation launched July 2024), and Celltrion’s Avtozma® (January 2025).  Fresenius Kabi’s Tyenne® SC was the first SC tocilizumab formulation to launch in the US.

Gedeon Richter & Hetero Labs Enter Global Collaboration for Generic Ozempic®

On 10 June 2026, Gedeon Richter and Indian-headquartered Hetero Labs announced that they have entered a global collaboration agreement to jointly develop, register and commercialise a generic semaglutide injection, referencing Novo Nordisk’s Ozempic®.  The companies are intending to submit EU and US regulatory filings in 2027.

The collaboration aims to take advantage of Hetero’s market reach in the US and emerging markets and Richter’s commercial infrastructure across Europe and Central Asia, while retaining the option for Richter to manufacture in Europe in future.

Numerous generic semaglutide products launched on the Indian market in March 2026, including by Dr Reddy’s Zydus, Alkem, Sun Pharma and Glenmark, following expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

GlycoNex Completes Ph 3 Equivalence Study for Biosimilar Denosumab in Japan

On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia® (denosumab).  SPD8 was co-developed by GlycoNex with Mitsubishi Gas Chemical.

GlycoNex and Mitsubishi Gas Chemical plan to complete the clinical study report by the end of September 2026 and file marketing approval applications in Japan in Q3 2026, referencing both Amgen’s Prolia® and Xgeva®.  A regulatory filing in Taiwan is planned for 2027, with a target launch date by end-2027.

There is one approved denosumab biosimilar in Japan, Alvotech’s AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection; September 2025), biosimilar to Daiichi Sankyo’s Ranmark® (marketed in other countries as Amgen’s Xgeva®).

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

New Indication Alert: Shanghai Henlius’ Serplulimab Approved in China for Perioperative Gastric Cancer

On 9 June 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved a new indication of Hansizhuang® (serplulimab, marketed as Hetronifly® in EU), in combination with Oxaliplatin and S-1.  The new indication is the neoadjuvant treatment of resectable gastric cancer with tumour PD-L1 expression CPS ≥ 5, followed by adjuvant monotherapy after surgery.

Henlius says the approval means that serplulimab is the first and only anti-PD-1 mAB in the world that has been approved for perioperative treatment of gastric cancer.

Henlius’ serplulimab received its first approval from China’s National Medical Products Administration (NMPA) in November 2022, for the first-line treatment (in combination with carboplatin and paclitaxel) of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC).  It has also been approved in China for ES-SCLC, ESCC and nsqNSCLC.  Henlius launched serplulimab as Hansizhuang® in certain Asian countries, including China, in August 2024.

Hetronifly® received a positive opinion from the European Medicines Agency’s CHMP for extensive-stage small cell lung cancer (ES-SCLC) in September 2024.  In February 2025, it was approved by the EC for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with ES-SCLC.  It has since been approved in other countries for this indication, including the UK and India (June 2025).  In May 2026, Hetronifly® was also approved in the EU for combination use in treating (a) certain metastatic oesophageal squamous cell carcinomas; and (b) certain non-squamous non-small cell lung carcinomas.

Mabpharm Secures Fourth Approval in China with Denosumab Biosimilar

On 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe), biosimilar to Amgen’s Prolia®, for the treatment of osteoporosis in postmenopausal women at increased fracture risk, osteoporosis in men at high fracture risk, and glucocorticoid-induced osteoporosis.  The approval marks Mabpharm’s fourth marketed product in China.

Mabpharm also indicated that its CMAB807X (Leishu®), biosimilar to Amgen’s Xgeva®, targeting oncology indications, such as bone metastases and giant cell tumour of bone, is expected to receive approval in the near future.

Mabpharm’s growing commercial portfolio in China already includes Leiting® (infliximab; July 2021), Aomaishu® (omalizumab; May 2023) and Enlituo® (cetuximab; June 2024).

Mabpharm enters an increasingly competitive denosumab biosimilar landscape in China.  Earlier approvals include Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®), and Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®).

Alvotech’s Biosimilar Vedolizumab BLA First to be Accepted for Review by FDA

On 8 June 2026, Alvotech announced that its Biologics License Application (BLA) for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), has been accepted for review by the FDA.  AVT16 is presented in a lyophilised vial for intravenous administration.  This is the first reported FDA application for a vedolizumab biosimilar.

According to Alvotech’s announcement, under a partnership with Teva, Alvotech is responsible for the development and manufacturing of AVT16, while Teva is responsible for its commercialisation.  Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.

Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), having announced positive results from a PK study for the product in February 2026.

Other vedolizumab biosimilars are in development, including Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (global licensing agreement with Fresenius Kabi (excluding MENA region) entered in August 2025, licensing agreement with MS Pharma for MENA region signed in September 2025).  In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development and, in March 2026, Sandoz announced it entered into a global licence, development and commercialisation agreement (excluding certain Asian countries) with Samsung Bioepis for up to five biosimilars, including vedolizumab.

Shanghai Henlius Doses First US Patient in Ph 1 Biosimilar Pembrolizumab Trial

On 5 June 2026, Shanghai Henlius Biotech announced that the first US patient has been dosed in its international Phase 1 clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study had previously completed first patient dosing in China.

The Phase 1 study, initiated in September 2025, is designed to evaluate the pharmacokinetic (PK) profile, efficacy, safety and immunogenicity of HLX17 versus US-sourced Keytruda® in patients with multiple resected solid tumours, including non‑small cell lung cancer, melanoma, or renal cell carcinoma.  Primary completion of the study is expected in April 2027.

A second study (integrated Ph 1/3) was initiated by Henlius in April 2025 to evaluate the efficacy, safety PK profile and immunogenicity of HLX17 versus Keytruda® in the first-line treatment of advanced nsNSCLC.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region,  and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

New Changes To Divisional Practice In New Zealand

On 2 June 2026 the New Zealand Parliament passed an amendment to the Patents Act 2013 (2013 Act). The 2013 Act replaced the Patents Act 1953. The 2013 Act included transitional provisions that allowed patent applications filed under the 1953 Act, and any divisional patent applications relating to them, to be considered under the earlier and more lenient 1953 Act. With no deadline for filing divisionals, and the ability to indefinitely “daisy-chain” further divisional applications, this has long been perceived as a problem.

The new amendment Act aims to cure that problem by providing that any future 1953 Act divisional applications will only be accepted for grant if the Commissioner of Patents is satisfied on the balance of probabilities standard, that the invention claimed in the application meets the novelty, inventive step and support requirements of the 2013 Act. These criteria will also apply to any opposition, revocation, and re-examination proceedings concerning these divisional applications.

While the amendment signals a clear legislative intent to close the gap between the legacy and modern patent regimes, it received criticism at both draft stage and before a Parliamentary committee, for being made too late to make any practical difference.  This reform was first proposed by the government as long ago as 2016.  At that time, there were still a significant number of 1953 Act applications under examination from which divisionals could be filed.  During the legislative process, the number of these applications has dwindled from around 70, when the draft amendment Bill was published, to 52 when it was passed by Parliament. Of these 52, 27 are owned by the medtech company Resmed, which has been involved in a long-running legal battle with New Zealand company Fisher & Paykel Healthcare.

The Amendment Act will come into force once it receives Royal assent, leaving a window of perhaps a few days from now for any last-minute divisionals to be filed for examination under the 1953 Act standard.  Those keeping a watch on any 1953 Act applications ought to be aware that any divisionals filed after that Assent is given will be examined under the higher modern standard.  Oppositions to these may have a higher chance of success, compared to their parent applications, as they will be considered under that same higher standard.

Updates on the Bill and its passing into law can be viewed here

If you would like tailored advice on any of the developments covered, our team would be pleased to assist. Contact info@pearceIP.law.


 

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

 

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Sally Paterson

Sally Paterson

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

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Mathew Lucas

Mathew Lucas

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

Mathew Lucas is an Executive Patent & Trade Mark Attorney with over 25 years’ experience in patent prosecution, oppositions, freedom-to-operate advice, litigation support, and strategic IP advice, focusing on the life sciences sector including pharma/biopharma, chemistry, materials science, diagnostics and biotechnology.  He has drafted more than 500 patent specifications across a wide range of technologies.

Mat holds a PhD in Chemistry from the University of Melbourne and completed post-doctoral research at the University of Illinois (Chicago) and the University of Adelaide in areas including radical chemistry, diagnostic technologies and therapeutic compounds.

Health Canada Accepts Kashiv’s Omalizumab Biosimilar Application

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.

The Canadian filing follows a series of regulatory advances for ADL-018.  Marketing applications for ADL-018 were accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March 2025 and by the European Medicines Agency (EMA) in October 2025.

Beyond Canada, Kashiv has agreements for the commercialisation of ADL-018 with Brazilian pharmaceutical company, CRISTÁLIA, for the Latin American market (11 August 2025) and MS Pharma for MENA markets (August 2025).

The only omalizumab biosimilar currently approved in Canada, and anywhere else in the world, is Celltrion’s Omlyclo®.  Omlyclo® was approved in Canada in 75mg and 150mg formulations in December 2024 and in 300mg PFS and autoinjector presentations in January 2026.

Omlyclo® has also been approved in: the EU (May 2024 and November 2025 (300mg)); Korea (June 2024 (PFS), December 2025 (autoinjector), 300mg formulation launched 30 March 2026)); Australia (November 2024); the US (March 2025 (75 mg/0.5ml and 150 mg/ml PFS) and December 2025 (300mg)); New Zealand (April 2025); and Japan (March 2026).  Celltrion commenced its European rollout of Omlyclo® 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.

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

BioImmunity Seeks Approval of Biosimilar Canakinumab in Russia

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab) and is seeking approval in Russia.  If registered, this will become the second canakinumab biosimilar approved in Russia after Generium’s Limiris™ (September 2025).

There have not been any reports of canakinumab biosimilars approved elsewhere.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar (AVT48) in Europe.

Alvotech Resubmits US BLAs for Aflibercept & Golimumab Biosimilars

On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.  Alvotech expects the FDA to conduct a 6-month review of the resubmitted BLAs, in line with applicable regulatory timelines.  Both AVT05 and AVT06 will be commercialised in the US by Teva.

The BLAs were resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility and the provision by Alvotech of responses to observations raised as a result of that inspection.  Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab (AVT03) biosimilar BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  In September 2025, AVT05 was the first golimumab biosimilar to be approved worldwide, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.  Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.

AVT06 (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement between Alvotech and Regeneron/Bayer.  AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®).  The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  There are a number of approved aflibercept biosimilars, some of which have scheduled H2 2026 launch dates as a result of litigation settlements, including Biocon’s Yesafili® (approved May 2024due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024due to launch Q4/2026), and Celltrion’s Eydenzelt® (approved October 2025due to launch Q4/2026).

Dr Reddy’s, Alvotech’s partner in the US for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), is responsible for resubmitting the BLA for that biosimilar.  AVT03 is currently the subject of BPCIA litigation commenced by Amgen in November 2025 alleging infringement of 31 US patents.

Pearce IP BioBlast® for the week ending 29 May 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 May 2026 are set out below:


Aflibercept

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct… Read more here.

Bevacizumab

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for… Read more here.

Daratumumab

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and… Read more here.

Denosumab

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg)… Read more here.

Guselkumab

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab)… Read more here.

Natalizumab

On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the… Read more here.

Pertuzumab

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as… Read more here.

Secukinumab

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®… Read more here.

Trastuzumab

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC… Read more here.

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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

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 LawExecutive 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 1000IAM 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.

Chantal Savage

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

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.

FDA Approves Lupin’s Biosimilar Ranibizumab & Accepts Xbrane’s Resubmitted Ranibizumab BLA

On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularization.

The following day, on 3 June 2026, Xbrane announced that the FDA accepted its biosimilar ranibizumab BLA, which has been given a Biosimilar User Fee Act (BsUFA) action date of 29 October 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 Valorum Biologics, which will be responsible for commercialising the product in the US under the name Lucamzi™.

Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025.  This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

The first ranibizumab biosimilar approved in the US was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022rights acquired by Sandoz from Coherus in March 2024), 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®, and was launched in the EU in April 2023.  Lupin’s Ranluspec® was approved in the EU in February 2026, where it is being commercialised by Sandoz under an August 2025 agreement.

Daewoong and Chime Biologics Partner on Biosimilar Dupilumab

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation (CDMO), Chime Biologics, announced that they have entered a strategic partnership agreement for the development, manufacture and commercialisation of a biosimilar of Sanofi/Regeneron’s Dupixent® (dupilumab).

Under the agreement, Chime will support the development and manufacture of Daewoong’s dupilumab biosimilar, while both companies will collaborate on commercialisation.

Although Daewoong has previously partnered on biosimilars in the Korean market (for example, promoting and launching Celltrion’s denosumab biosimilars in Korea), the dupilumab agreement with Chime is intended to be the foundation of its biologics expansion strategy, building the Dupixent® biosimilar into a global product.

Biosimilar dupilumab is under development by at least Samsung BioepisBio-Thera Solutions and Costa Rican-based SteinCaresAlvotech and Advanz, Binnopharm and Mabwell and Amneal.  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.  In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

Celltrion Files Canadian Application for Biosimilar Secukinumab

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications.  Celltrion is also planning regulatory filings for CT-P55 in the US, Europe and Korea.

According to Celltrion, its first biosimilar secukinumab application was filed in Canada on the basis that it is a “pro-biosimilar nation” and pursues “policies to promote the introduction of biosimilars and [improve] its regulatory environment”.

The Canadian application is based on Celltrion’s Phase 1 trials, results of which were presented in September 2025.  In February 2026, Celltrion received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.

Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

New Indication Alert: BMS’ Nivolumab Combo EU-Approved for cHL

On 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adults and adolescents over 12 years of age with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).  The Opdivo® plus AVD combination is the first immunotherapy-based regimen available in the EU for newly diagnosed advanced cHL.

This cHL indication was recommended by the CHMP in April 2026 and approved by the FDA in March 2026.  BMS also added another cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898Xbrane/Intas’ Xdivane™Amgen’s ABP 206Reliance Life Sciences’ RLS-NivolumabEnzene’s candidateBoan Biotech’s BA1104NeuClone’s candidate and Zydus’ ZRCr-4276.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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