Shanghai Henlius Biotech and Organon have obtained US approval for their Perjeta biosimilar, Poherdy (pertuzumab-dpzb).
This makes it the first interchangeable Perjeta biosimilar to gain approval from the US Food and Drug Administration (FDA).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Like its branded counterpart, Poherdy will be available to patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer. It will also be indicated for use in combination with trastuzumab and chemotherapy in both the adjuvant and neoadjuvant settings.
This follows a comprehensive review from the FDA, which found that Poherdy is “highly similar to Perjeta”, with no clinically meaningful differences in efficacy and safety observed between the two products.
The agency made this call based on the results of a pharmacokinetic (PK) study in healthy adults, as well as a Phase III trial in the neoadjuvant HER2-positive, HR-negative breast cancer setting.
Poherdy’s approval comes after the FDA debuted plans to simplify the interchangeable biosimilar development process, which is set to help patients and prescribers identify low-cost brand alternatives more easily.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataOrganon’s commercial hurdle
Following Poherdy’s approval, Organon will be responsible for the drug’s commercialisation across the US. This follows Henlius’ choice to out license the drug’s ex-China rights to Organon in 2022, which saw the latter hand over $103m for Poherdy and a Prolia/Xgeva (denosumab) biosimilar in 2022.
These licensing deals are not the only moves the company has made to expand its biosimilar portfolio, as Organon also acquired the rights to Biogen’s Actemra (tocilizumab) biosimilar, Tofidence, in April 2025.
Despite its newfound approval, Poherdy’s market entry may not be smooth sailing, as Perjeta maker Genentech is looking to hold back the tides on biosimilar competition for a little longer.
In a bid to achieve this, the Roche subsidiary filed a lawsuit in August 2025 in the district of New Jersey, alleging that Shanghai Henlius Biotech and Organon are infringing on 24 US patents covering Perjeta’s market exclusivity. A verdict is yet to be reached.
However, Genentech’s attempt to curb the sales losses of Perjeta comes as the drug’s sales are already experiencing a steady decline since its $4.3bn peak in 2021, according to GlobalData analysis. The same analysis predicts that sales in 2024 dropped to $4.1bn.
Looking forward to 2031, analysts at GlobalData expect this trend to continue, as the drug is expected to bring in less than a quarter of its 2021 income, producing just $797m in sales.
GlobalData is the parent company of Pharmaceutical Technology.
The profit drop experienced by Genentech may be further exacerbated by the potential market introduction of new biosimilars, including EirGenix’s Perjeta mimic. Sandoz recently acquired the global commercial rights to the biosimilar outside of certain countries in Asia.
