On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive opinions, recommending the granting of a marketing authorization for two biosimilar medicines: Henlius’ Poherdy (pertuzumab) and Gedeon Richter’s Tuyory (tocilizumab). Additionally, Henlius marks the first anniversary of the European Commission’s (EC) approval of its novel biological, Hetronifly (serplulimab).
Poherdy (pertuzumab)
Shanghai Henlius and Organon’s Poherdy (HLX11) is a biosimilar of Roche’s Perjeta (pertuzumab). It is a monoclonal antibody approved for treating HER2-positive breast cancer [1].
Developed by Henlius, Poherdy is approved for all indications of the reference product in the European Union, including both metastatic and early-stage breast cancer. Poherdy will be available as a 420 mg concentrate for solution for infusion.
The proposed indication for HLX11 is for use in combination with trastuzumab and docetaxel in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for their metastatic disease.
The CHMP’s positive opinion was based largely on a comprehensive review of analytical similarity and clinical comparative studies, which demonstrated similarity to the reference product in quality, safety, and efficacy.
In 2022, Henlius signed a license and supply agreement with Organon, giving Organon exclusive global commercialization rights to multiple biosimilars, including HLX11 — excluding China [2].
In November 2025, Poherdy, became the first pertuzumab biosimilar approved by US Food and Drug Administration (FDA) [3], where it has also received the interchangeable designation. This includes its role in neoadjuvant and adjuvant treatment as part of standard combination therapy regimens. The 420 mg/14 mL intravenous injection is fully interchangeable with the reference product.
Hetronifly (serplulimab)
Hetronifly (serplulimab/HLX10), a novel biological developed by Henlius, was approved in Europe in February 2025. It has now launched in 12 EU countries and is included in reimbursement schemes in Germany, Italy, Spain and other Member States. Additionally, it has been approved in over 40 countries and regions worldwide, covering nearly half of the global population. In Europe, the product is used in combination with carboplatin and etoposide as a first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
These Henlius biosimilar products have been in development since at least 2021 and have been able to enter global markets following patent expiration [4].
Tuyory (tocilizumab)
Gedeon Richter’s Tuyory is a biosimilar of Roche’s Actemra (tocilizumab), a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R) [5]. Tuyory is approved for the treatment of COVID-19 virus infection, cytokine release syndrome, giant cell arteritis, juvenile arthritis, and rheumatoid arthritis. It will be available as a 20 mg/ml concentrate for solution for infusion and a 162 mg solution for injection in pre-filled syringe or pre-filled pen.
Regulatory Context
In January 2026, six new medicines were recommended for approval by the EMA, with no biosimilars approved during that month.
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pertuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Organon–Henlius partnership: biosimilars for women’s health [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-poherdy-first-interchangeable-pertuzumab-and-armlupeg-pegfilgrastim-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Patent expiries may drive development of copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/reports/Patent-expiries-may-drive-development-of-copy-biologicals-in-China
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
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