Other Updates

On 1 July 2026, The Korea Biomedical Review reported that Samsung Epis Holdings has opened and commenced operating its new research and development centre in Beijing.  The establishment of the new R&D centre was first announced by Samsung Epis on 29 May 2026.

The R&D centre is operated by Samsung Bioepis (China), a wholly owned subsidiary of Samsung Epis Holdings, and will serve as a global R&D hub supported by “world-class scientific talent and advanced technological infrastructure in China”.  The centre will have a strategic focus on securing antibody-drug conjugate (ADC) technology platforms and strengthening Samsung’s capabilities in new drug development.

On 1 July 2026, Australia’s Pharmaceutical Benefits Scheme published its Summary of Changes, which includes a newly PBS-listed ustekinumab biosimilar and new or expanded PBS-listings for a number of biopharmaceuticals.

The newly PBS-listed ustekinumab biosimilar is Amgen’s Wezlana®, biosimilar to Janssen’s Stelara®, which is PBS-listed for the treatment of inflammatory conditions.  Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time.  Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.

The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (1 August 2025).  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

The biopharmaceuticals PBS-listed from 1 July 2026 include:

• Novo Nordisk’s Tresiba® Penfill® (insulin degludec) for the treatment of type 1 diabetes, which was originally rejected for PBS listing back in March 2013 due to safety and cost considerations;
• UCB’s Rystiggo® (rozanolixizumab) for treatment of generalised myasthenia gravis (gMG), which was recommended by PBAC for reimbursement in March 2025; and
• AstraZeneca’s Tezspire® (tezepelumab) for the treatment of severe uncontrolled asthma, which was recommended for reimbursement in November 2025 after AstraZeneca had withdrawn an earlier PBAC listing request in July 2022.

In addition, Roche’s PBS listing for Perjeta® (pertuzumab) has been expanded to include the treatment of high-risk HER2+ early breast cancer.  Perjeta® was first approved by the TGA in May 2016 and the new indication was recommended by the PBAC for reimbursement in March 2025.

On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar in the US to earn this designation.  As the first interchangeable rituximab biosimilar in the US, Truxima® has a 1-year exclusivity period, during which the FDA cannot approve subsequent interchangeable versions of Rituxan®.

Truxima® was launched in the US in May 2020 and is approved for all non-paediatric indications of Rituxan®, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and microscopic polyangiitis.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to become biosimilar.  In addition to Truxima®, Amgen/Allergan’s Riabni® (approved December 2020) and Pfizer’s Ruxience® (launched January 2020) are the only rituximab biosimilars approved in the US market, with Dr Reddy’s biosimilar rituximab being knocked back by the FDA in April 2024.

On 1 July 2026, Samsung Bioepis and Harrow announced the relaunch of Byooviz® (ranibizumab), biosimilar to Genentech’s Lucentis®, in the US.

The relaunch follows the transition of Biogen’s commercialisation rights for biosimilar ranibizumab (and biosimilar aflibercept) back to Samsung Bioepis after Biogen terminated a November 2019 agreement with Samsung Bioepis for the US and Canada.  Samsung Bioepis entered into a partnership with Harrow in July 2025 for the US commercialisation of Byooviz® (and Opuviz® (aflibercept)) on full return of the commercial rights.

Byooviz® was approved in the US in September 2021 for the treatment of patients with neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation.  It was originally launched in the US in June 2022 and was granted interchangeability designation by the FDA in October 2023.

The following ranibizumab biosimilars are also approved in the US: Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).

On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.

Celltrion announced the Korean approval of the autoinjector presentation of Omlyclo®, biosimilar to Novartis’ Xolair®, in December 2025.  The launch comes three months after Celltrion’s Korean launch of its high dose (300 mg) Omlyclo® formulation.

Celltrion’s Omlyclo® (CT-P39) is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil, while in January 2026, high dose Omlyclo® (PFS and autoinjector) was approved in Canada.

Kashiv BioSciences/Alvotech are likely to be the next companies with an approved omalizumab biosimilar on the market.  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.  An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

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).

On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab), in Japan.  The partner to the deal has not been identified but is said to be a “leading Japanese pharmaceutical company”.

Under the agreement, EirGenix will provide CMC-related know-how and product-related information necessary for regulatory activities, while remaining responsible for product development, manufacturing, and commercial supply.  The Japanese partner will lead regulatory approval activities and commercialisation in Japan.

According to EirGenix, a pharmacokinetic clinical study for EG1206A has been completed and the biosimilar has received positive feedback from both the FDA and the European Medicines Agency regarding the feasibility of an abbreviated development pathway, including the waiver of Phase 3 comparative efficacy trials.

In 2025, EirGenix entered into a global commercialisation deal with Sandoz for EG1206A which excluded Japan and a number of other countries in Asia.  This followed a 2023 deal between the same companies relating to EirGenix’s trastuzumab biosimilar Herwenda® (referencing Genentech’s Herceptin®).

Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US, EU, and China (as Hanbeiyou®).  Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.

On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare, to commercialise in Europe Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

Under the agreement, Orion will have the exclusive right to distribute, market and sell Shilpa’s biosimilar nivolumab in Europe, while Shilpa will supply the product to Orion and is entitled to receive certain confidential development and regulatory milestone payments.

BMS’ originator nivolumab (Opdivo®) is approved in Europe for various indications including:

• classical Hodgkin Lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD) and in combination with brentuximab vedotin;
• resectable non-small cell lung cancer;
• unresectable or advanced hepatocellular carcinoma in combination with Yervoy® (ipilimumab);
• MSI-H or dMMR unresectable or metastatic colorectal cancer in combination with Yervoy®
• melanoma; and
• metastatic gastric, gastroesophageal junction, or oesophageal adenocarcinoma.

A number of other 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.

Orion has an existing distribution agreement for Europe with CuraTeQ in relation to unidentified biosimilars, while Shilpa announced a commercialisation deal with SteinCares for an undisclosed biosimilar in Latin America in February 2026.

On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide).  Sevmia™ is the first generic semaglutide product approved in Canada for chronic weight management.

Sevmia™ was developed in partnership with Orbicular Pharmaceutical Technologies and is approved as a solution for subcutaneous injection in a pre-filled pen (4 mg/pen; 1.34 mg/mL).  It is indicated for once-weekly treatment of patients aged 12 years and over, as a supplement to a reduced calorie diet and increased physical acitivity for chronic weight management.

Generic semaglutide products have previously been approved in Canada only for the treatment of type 2 diabetes.  Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched in Canada on 14 May 2026.

Health Canada is reviewing numerous submissions for generic semaglutide, including applications by AA Pharma, Aspen Pharmacare, Teva, Taro Pharmaceuticals, Zydus Lifesciences and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the reference product, MSD’s Keytruda®.  According to Samsung Bioepis, it is the first developer of a pembrolizumab biosimilar to announce global phase 3 clinical trial results.

The news follows reports published on 5 May 2026 announcing positive preliminary Phase 1 data for SB27, which were subsequently withdrawn from a number of news sites.  The Phase 1 and Phase 3 trials were both commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 2026.

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 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has previously 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 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.

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma has been accepted for review by the FDA.  A target date for the FDA’s decision has been set for 2 August 2026.

Replimune’s plan for resubmission was reported in May 2026, following the rejection of two earlier submissions in July 2025 (first Complete Response Letter (CRL) issued in response to a November 2024 BLA submission) and April 2026 (second CRL issued in response to an October 2025 BLA submission).

In May 2026, the FDA indicated it would treat Replimume’s BLA resubmission as an urgent matter upon receipt and would prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.