Pearce IP BioBlast® for the week ending 22 May 2026

May 26, 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 22 May 2026 are set out below:

Aflibercept

19 May 2026 | EU | Formycon/Klinge Launch Aflibercept Biosimilars in EU

On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced… Read more here.

Denosumab

21 May 2026 | CN | New Indication Alert: Mabwell Expands Reach of its Biosimilar Denosumab in China with New Indications

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to… Read more here.

Pembrolizumab

20 May 2026 | KR | MSD’s Subcutaneous Keytruda® Approved in Korea; Q4/26 Launch Planned

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and… Read more here.

Ranibizumab, Liraglutide

22 May 2026 | EU | CHMP Positive Opinions for May 2026 Include Lupin’s Biosimilar Ranibizumab & STADA’s Hybrid Liraglutide

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including… Read more here.

Semaglutide

20 May 2026 | Zydus Plans Generic Semaglutide Rollout Across 20+ Markets Over Next Two Years

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the… Read more here.

22 & 23 May 2026 | EU | Novo Nordisk Secures CHMP Backing for Oral & High-Dose Semaglutide

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of… Read more here.

Ustekinumab

20 May 2026 | JP | Samsung Bioepis Launches Ustekinumab Biosimilar in Japan

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner… Read more here.

Biopharma Deals

22 May 2026 | LATAM | Polpharma Biologics Inks Exclusive Licensing Deal with Tuteur for Autoimmune Disease Biosimilar in LATAM

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar… Read more here.

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

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

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

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

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Chantal Savage

Special Counsel, Lawyer

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

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

Maliha Hoque

Paralegal

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

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Polpharma Biologics Inks Exclusive Licensing Deal with Tuteur for Autoimmune Disease Biosimilar in LATAM

May 22, 2026

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the product, while Argentina-based Tuteur will be responsible for the commercialisation, marketing and distribution across Latin America, excluding Brazil.

The unnamed biosimilar is currently in development, with the companies anticipating a regulatory submission to be filed within the next three years.

In December 2025, Polpharma Biologics entered into an exclusive licensing agreement with Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil. This deal followed a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®). In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

Novo Nordisk Secures CHMP Backing for Oral & High-Dose Semaglutide

May 22, 2026

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of Novo Nordisk’s semaglutide:

Wegovy® pill (once-daily oral semaglutide 25 mg); and
high-dose Wegovy® 7.2 mg (once-weekly injectable semaglutide) in a single-dose pen formulation,

The Wegovy® pill is the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU. It follows the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026. Eli Lilly’s Foundayo™ (orforglipron), the only other oral GLP-1 receptor therapy for weight loss, received US FDA approval on 1 April 2026 and became available to patients on 6 April 2026.

High dose Wegovy® expands the dosing options available in Europe, with Wegovy® currently available only as once-weekly treatment with three separate 2.4 mg injections administered one after each other. Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in Q3 2026 in Europe. Wegovy® 7.2 mg is already available in the US under the brand name Wegovy® HD.

CHMP Positive Opinions for May 2026 Include Lupin’s Biosimilar Ranibizumab & STADA’s Hybrid Liraglutide

May 22, 2026

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of biopharmaceuticals.

Lupin’s Vislyfa® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive opinion this month. There is already a Lupin-developed biosimilar approved in Europe, Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026). Under an August 2025 agreement, Sandoz is commercialising Ranluspec® in the EU (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia. Other ranibizumab biosimilars approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021 and commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval) and Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva). Intas’ Rexatilux® (ranibizumab) received a positive CHMP opinion in April 2026.

STADA received positive recommendations for its “hybrid” liraglutide products Ablymico® and STADA Liraglutide™, indicated for weight management and type 2 diabetes, respectively. The EMA categorises a medicine as “hybrid” where it is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form. Ablymico® is a hybrid medicine of Novo Nordisk’s Saxenda® (liraglutide), in that it contains the same active substance, but it is chemically synthesised, whereas the active substance of Saxenda® is of biological origin. For the same reason, STADA Liraglutide™ is a hybrid medicine of Novo Nordisk’s Victoza® (liraglutide).

The CHMP’s May 2026 positive opinions for extended indications include:

AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan): for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options;
MSD’s Erbitux® (cetuximab): for adults with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for first line treatment and in combination with encorafenib in patients who have received prior systemic therapy;
AstraZeneca’s Fasenra® (benralizumab): as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause;
Shanghai Henlius/Accord’s Hetronifly® (serplulimab): in combination with carboplatin and nab-paclitaxel, for first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma;
MSD’s Keytruda® (pembrolizumab): in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy;
MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase-alfa): indications extended to adolescents in relation to melanoma and classical Hodgkin Lymphoma; and
Astellas’ Padcev® (enfortumab vedotin): in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Celltrion withdrew its EU marketing authorisation application for Veblocema™ (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis “due to a change in business strategy”, while Laboratoires Delbert withdrew its application for Orblid™ (bevacizumab) for treatment of hereditary haemorrhagic telangiectasia, due to identification of major clinical issues which could only be addressed by carrying out a new clinical study.

New Indication Alert: Mabwell Expands Reach of its Biosimilar Denosumab in China with New Indications

May 21, 2026

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab), developed by its wholly-owned subsidiary T-mab. The drug is now approved to help delay or reduce skeletal-related events, including pathological fracture, spinal cord compression, and the need for bone surgery or radiotherapy, in patients with bone metastases from solid tumours or multiple myeloma.

This builds on Maiweijian™’s initial NMPA approval in March 2024, when it became the first denosumab biosimilar (120mg) approved for marketing in China, initially indicated for unresectable giant cell tumour of bone. Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.

Mabwell announced in April 2026 that it entered into a licensing and commercialisation agreement with an unidentified strategic business partner for Maiweijian™ and Mailishu® in Malaysia. Under the terms of the agreement, the partner is responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, while Mabwell is responsible for the development, manufacturing and supply of the biosimilars.

Mabwell completed its first commercial shipment of its denosumab biosimilars outside China in December 2025, although the destination(s) of the shipment was not disclosed in the press release. According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several markets, including Jordan, Egypt, and Brazil.

Samsung Bioepis Launches Ustekinumab Biosimilar in Japan

May 20, 2026

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner NIPRO Corporation. SB17 will be marketed in Japan as “Ustekinumab BS Subcutaneous Injection 45 mg “Nipro””.

SB17 was approved in Japan in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis. The product is being commercialised in Japan by NIPRO under the terms of a June 2025 agreement.

Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025), and Celltrion (July 2025).

The Japan launch forms part of Samsung Bioepis’ global launch plans, with Epyztek® (SB17) being the first ustekinumab biosimilar approved in South Korea in April 2024. SB17 has also been approved in Europe in April 2024 as Pyzchiva®, and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms. Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.

Zydus Plans Generic Semaglutide Rollout Across 20+ Markets Over Next Two Years

May 20, 2026

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the next two years.

Zydus was one of the first companies to launch generic semaglutide in India (marketed as Semaglyn™, Mashema™ and Alterme™) upon expiry of Novo Nordisk’s key Indian semaglutide patent in March 2026. Under agreements announced in March 2026, Lupin holds semi-exclusive rights to co-market Zydus’ semaglutide injection in India under the brand names Semanext® and Lupin’s Livarise®, while Torrent Pharmaceuticals holds semi-exclusive rights to co-market the product in India under its own brand name Sembolic™.

Zydus now has global partnerships and registration plans underway for other regions, subject to regulatory approvals. Sharvil Patel, Managing Director of Zydus, stated that the company expects to “see some launches this year and some in the next year”, although he admitted that Zydus “may not be part of the first wave” of generic semaglutide launches in some markets. However, Zydus considers its differentiated offering, including its reusable pen device, will “provide significant cost benefits to patients”.

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.

MSD’s Subcutaneous Keytruda® Approved in Korea; Q4/26 Launch Planned

May 20, 2026

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) for 35 indications across 18 cancer types. MSD plans to launch the product in Korea in Q4/2026.

This follows approval of Keytruda SC™ in Canada in February 2026 and in Europe in November 2025. MSD’s subcutaneous formulation of pembrolizumab was also approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

Halozyme has commenced patent infringement litigation against MSD in relation to subcutaneous pembrolizumab in Germany and the US. In December 2025, the Munich Regional Court granted a preliminary injunction to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™. The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions. Earlier in May 2026, MSD was successful in invalidating one of Halozyme’s US patents before the US Patent Trial and Appeal Board (PTAB). MSD has a further 17 petitions pending before PTAB.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development. 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). Pembrolizumab biosimilars are also in clinical trials including by Formycon, 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. Formycon has announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, Zydus Lifesciences for the US and Canada, and Lotus for the Asia-Pacific.

Pearce IP’s Annual Australian Patent Case Review 2025 – Now Available

May 20, 2026

Pearce IP is pleased to release the Annual Australian Patent Case Review 2025, a comprehensive, expert analysis of all patent decisions shaping the Australian legal landscape over the past year.

Spanning 130 pages, this essential resource provides a complete overview of:

All decisions delivered by the Federal Court of Australia
All decisions delivered by the Full Court on appeal
Significant decisions from the Australian Patent Office

In 2025, the Federal Court delivered 19 substantive patent decisions, alongside 6 key interlocutory decisions, while the Patent Office issued 8 significant rulings. Together, these decisions highlight important developments in patent law.

Our review identifies several major trends and developments regarding:

Pharmaceutical patent term extensions (PTEs)
Preliminary injunction strategies
Computer-implemented inventions
Validity challenges
Procedural developments
Litigation timelines to first instance and appeal decisions, across all registries
Forum selection

Complete the form to receive your copy via email.

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