Other Updates

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.

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.

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.

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.

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.

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.

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.

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).

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.

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®).