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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.

Alteogen’s Biosimilar Aflibercept Approved in Saudi Arabia

Jun 19, 2026

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.

Samsung Bioepis and Organon Expand Canadian Collaboration to Include Biosimilar Ustekinumab

Jun 18, 2026

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’ Pyzchiva® (SB17), biosimilar to J&J’s Stelara® (ustekinumab).  Current plans are for Pyzchiva® to be launched in Canada during 2026.

Under the terms of the expanded agreement, Organon will obtain the exclusive Canadian commercialisation rights to Pyzchiva®, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities.

The new agreement expands the biosimilar portfolio under Samsung Bioepis and Organon’s collaboration in Canada (first established in 2013) from five to six biosimilars.  In addition to Pyzchiva®, the biosimilars encompassed by the agreement are Hadlima® (adalimumab; launched 50mg/mL in March 2021; 100mg/mL approved August 2022), Brenzys® (etanercept; approved September 2016), Renflexis® (infliximab; launched March 2018), Aybintio® (bevacizumab; launched November 2022), and Ontruzant® (trastuzumab; launched November 2022).

Samsung Bioepis had previously entered into an exclusive agreement with Sandoz in September 2023 for the development and commercialisation of SB17 in the US, Canada, EEA, Switzerland and the UK.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

Pyzchiva® was approved in Canada in August 2024.  Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Biocon’s Yesintek™ (approved October 2025, launched mid-October 2025) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

CSPC Pharmaceutical’s Biosimilar Secukinumab MAA Accepted in China

Jun 18, 2026

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).

Sanofi & Alteogen Confirm Development of Subcutaneous Dupilumab

Jun 18, 2026

On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it announced in November 2019 for its ALT-B4 technology with an “undisclosed” pharmaceutical company was a deal with Sanofi regarding development of a high-dose subcutaneous formulation of Dupixent® (dupilumab).  ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.

The Sanofi deal was said by Alteogen in 2019 to potentially be worth up to USD 1.37 billion.  It has been disclosed that Sanofi paid USD13 million upfront in December 2019 and made two subsequent milestone payments, one in March 2020 for an undisclosed amount and a second of USD3 million in April 2023.  No details about the clinical stage of the development have been announced.

Alteogen has since partnered with a number of companies for the use of ALT-B4 in the subcutaneous formulations.  In November 2024, Alteogen signed an exclusive US$300 million licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous injection form of Enhertu® (trastuzumab deruxtecan).  In January 2026, Alteogen entered an exclusive licence agreement with Tesaro, a GSK subsidiary, for the use of ALT-B4 in the development and commercialisation of a subcutaneous formulation of dostarlimab.

Alteogen collaborates with MSD on subcutaneous Keytruda® (pembrolizumab).  MSD’s subcutaneous pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications and has also been approved in Europe (November 2025), Canada (February 2026) and Korea (May 2026).

In January 2023, Alteogen entered into an exclusive agreement with Sandoz for the use of ALT-B4 to develop a subcutaneous version of an undisclosed Sandoz biosimilar product, with an option for Sandoz to licence the Alteogen technology for two further products.

Sandoz Opens USD 99M Biosimilar Development Centre in Slovenia

Jun 17, 2026

On 17 June 2026, Sandoz announced the opening of its new biosimilar development centre in Ljubljana, Slovenia.  The construction of the fully digitally integrated USD 99 million facility was first announced in July 2025.

The centre will support end-to-end drug development and is fully integrated into the development network, including bioanalytical and bioassay laboratories in Holzkirchen, Germany and device development in Cambridge, UK.  The Slovenia biosimilar development centre is the first of three major investment projects in Slovenia, with Sandoz planning to invest a total of USD 1.1 billion across the three projects.

The new development centre joins Sandoz’s new facilities for drug production in Lendava, sterile production and packaging in Brnik and a biosimilar site acquired in Toulouse, France.  It follows Sandoz’s creation of a new global biosimilar development, manufacturing and supply unit, which came into effect on 1 April 2026.

According to Sandoz’s CEO, Richard Saynor, the new biosimilar development centre in Slovenia, together with Sandoz’s other manufacturing investments, will “help move biosimilars efficiently into production, supporting our ‘golden decade’ of more affordable healthcare, with approximately USD 320 billion in biologic patent expiries expected over the next decade”.

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

Jun 16, 2026

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.

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

 

Outlook Therapeutics’ Resubmitted Ophthalmic Bevacizumab BLA Accepted for Review by FDA

Jun 16, 2026

On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for review by the FDA.  The Prescription Drug User Fee Act (PDUFA) target date is 29 July 2026.

If approved, ONS-5010/Lytenava™ will be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA to treat wet AMD.  Outlook Therapeutics has commenced pre-launch activities in anticipation of the pending approval.

Since its initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA has issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025).  After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process.  In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

Pearce IP BioBlast® for the week ending 12 June 2026

Jun 15, 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.

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. 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 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 & Trade Mark Attorney (Trans Tasman)

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

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

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

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.

Celltrion Launches Bevacizumab & Rituximab Biosimilars in Vietnam

Jun 15, 2026

On 15 June 2026, Celltrion announced that it has launched its rituximab and bevacizumab biosimilars in Vietnam.  Truxima®, biosimilar to Roche/Genentech/Biogen’s Rituxan®/MabThera® (rituximab), and Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) were launched by Celltrion on 9 June 2026, following receipt of marketing authorisation three months earlier.

Celltrion now has four biosimilars on the market in Vietnam, having previously launched Remsima® (infliximab) and Herzuma® (trastuzumab) in August 2025.  Celltrion plans to leverage marketing synergies between the four products to accelerate prescriptions and is planning to introduce follow-up products into the Vietnamese market, including Remsima® SC.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

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 approved in the US: 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.

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

Jun 12, 2026

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

Jun 12, 2026

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

Jun 11, 2026

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

Jun 11, 2026

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

Jun 10, 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.

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. 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 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 & Trade Mark Attorney (Trans Tasman)

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

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

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

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

Jun 10, 2026

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

Jun 10, 2026

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 2023; launched 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 2024; IV formulation launched April 2024; SC 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®

Jun 10, 2026

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

Jun 10, 2026

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 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), 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), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched 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

Jun 9, 2026

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

Jun 9, 2026

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

Jun 8, 2026

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

Jun 5, 2026

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

Jun 4, 2026

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.

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. 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 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.

Health Canada Accepts Kashiv’s Omalizumab Biosimilar Application

Jun 4, 2026

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).

Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | Eli Lilly/Merck KGaA

daratumumab | Darzalex® | J&J

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

lecanemab | Leqembi® | Eisai/Biogen

liraglutide | Victoza® /Saxenda® | Novo Nordisk

natalizumab | Tysabri® | Biogen/Elan

nivolumab | Opdivo® | BMS

olaparib | Lynparza® | AstraZeneca/Merck

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | MSD

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

semaglutide | Wegovy®/Ozempic® | Novo Nordisk

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

vedolizumab | Entyvio® | Takeda

View latest BioBlast® updates

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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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