On 13 November 2025, the US Food and Drug Administration (FDA) approved Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s Perjeta. Additionally, on 28 November 2025, the FDA approved Lupin’s pegfilgrastim biosimilar, Armlupeg (pegfilgrastim-unne).
Poherdy (pertuzumab-dpzb)
Poherdy (pertuzumab-dpzb), developed by Shanghai Henlius, the first and only pertuzumab biosimilar approved and available in the US. The 420 mg/14 mL intravenous injection is fully interchangeable with the reference product, Perjeta.
Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, thereby preventing signalling pathways that promote cell growth and proliferation [1]. As such, it is used in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen for early breast cancer; and as adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
Approved for treating HER2-positive breast cancer, Poherdy (pertuzumab-dpzb) is indicated for use in both metastatic and early-stage settings. This includes its role in neoadjuvant and adjuvant treatment as part of standard combination therapy regimens.
The US approval was based on a comprehensive data package demonstrating analytical similarity, pharmacokinetic equivalence, and comparable safety and efficacy to the reference product.
This milestone stems from a license and supply agreement established between Henlius and Organon in 2022. The agreement grants Organon exclusive global commercialization rights for multiple Henlius biosimilars, including Poherdy, outside of China. The approval strengthens the partners' shared oncology portfolio and enhances their ability to deliver quality biologics to more patients worldwide [2 ,3].
The approval of Poherdy (pertuzumab-dpzb) follows the UK’s approval of Shanghai Henlius’ Bildyos (denosumab) and Bilprevda (denosumab) on 11 November 2025 [1].
Armlupeg (pegfilgrastim-unne)
Armlupeg (pegfilgrastim-unne) is FDA-approved to reduce the risk of febrile neutropenia—a common and serious side effect of chemotherapy—in adults with nonmyeloid cancers. Chemotherapy can cause severe neutropenia, or low white blood cell counts, significantly raising the risk of life-threatening infections. Armlupeg addresses this by stimulating the bone marrow to increase white blood cell production.
The biosimilar is administered as a single 6-mg/0.6-mL subcutaneous injection per chemotherapy cycle.
Following its FDA approval, Lupin announced in early December 2025 an exclusive U.S. licensing agreement with Valorum Biologics, a US-based biosimilar specialist. Under the agreement, Valorum will handle all commercialization and distribution of Armlupeg in the US, while Lupin retains responsibility for manufacturing and supply. Lupin will receive an upfront license fee and ongoing royalties based on net sales.
Armlupeg was first approved in Canada on 23 August 2024 [5]. In the US, it enters a biosimilar market currently served by only one other approved pegfilgrastim biosimilar: Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk), which received FDA approval in September 2022.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 27]. 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 Jan 27]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health
3. GaBI Online - Generics and Biosimilars Initiative. Chinese biosimilars go global: growth, partnerships, and challenges [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 27]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 27]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-insulin-glargine-biosimilar-ondibta-and-denosumab-biosimilar-osqay
5. GaBI Online - Generics and Biosimilars Initiative. Canada approves pegfilgrastim biosimilar Armlupeg [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jan 27]. Available from: www.gabionline.net/biosimilars/news/canada-approves-pegfilgrastim-biosimilar-armlupeg
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