FDA Approves First Perjeta Biosimilar as Shanghai Henlius and Organon Secure Interchangeable Status
核心洞察
The FDA has approved Poherdy (搜索) (pertuzumab-dpzb (搜索)) as the first interchangeable biosimilar to Genentech's Perjeta, marking a significant milestone in HER2 (搜索)-positive breast cancer treatment accessibility.
Shanghai Henlius Biotech (搜索) and Organon's biosimilar received approval for all the same indications as the reference drug, including metastatic, adjuvant, and neoadjuvant HER2 (搜索)-positive breast cancer settings.
The approval comes amid ongoing patent litigation from Genentech and declining Perjeta sales, which dropped from $4.3 billion in 2021 to $4.1 billion in 2024.
The US Food and Drug Administration has approved Poherdy (搜索) (pertuzumab-dpzb (搜索)), developed by Shanghai Henlius Biotech (搜索) and Organon, as the first interchangeable biosimilar to Genentech's Perjeta (pertuzumab). The November 13, 2025 approval represents a significant development in expanding access to HER2 (搜索)-positive breast cancer treatments.
Comprehensive Indication Coverage
Poherdy (搜索) received approval for all the same indications as its reference product, making it available for patients with human epidermal growth factor receptor 2 (搜索) (HER2 (搜索))-positive, metastatic breast cancer. The biosimilar is also indicated for use in combination with trastuzumab and chemotherapy in both adjuvant and neoadjuvant treatment settings.
The FDA's approval followed a comprehensive review that determined Poherdy (搜索) is "highly similar to Perjeta" with no clinically meaningful differences in efficacy and safety observed between the two products. This determination was based on results from a pharmacokinetic study in healthy adults and a Phase III trial in the neoadjuvant HER2 (搜索)-positive, HR-negative breast cancer setting.
Commercial Strategy and Patent Challenges
Organon will handle commercialization of Poherdy (搜索) across the United States following Henlius' decision to out-license the drug's ex-China rights in 2022. The licensing agreement, valued at $103 million, included both Poherdy and a Prolia/Xgeva (denosumab) biosimilar.
However, market entry may face obstacles due to ongoing patent litigation. Genentech filed a lawsuit in August 2025 in the District of New Jersey, alleging that Shanghai Henlius Biotech (搜索) and Organon are infringing on 24 US patents covering Perjeta's market exclusivity. A verdict has not yet been reached in Case No. 2:25-cv-14648 (D.N.J.).
Market Impact and Financial Projections
The biosimilar approval comes as Perjeta experiences declining sales performance. According to GlobalData analysis, the drug's revenue has dropped from its $4.3 billion peak in 2021 to $4.1 billion in 2024. Roche reported US sales of approximately $1.486 billion for Perjeta in 2024.
Analysts project this downward trend will continue, with GlobalData forecasting Perjeta sales to fall to less than a quarter of its 2021 income by 2031, generating just $797 million in revenue. The introduction of additional biosimilar competition, including EirGenix (搜索)'s Perjeta biosimilar for which Sandoz recently acquired global commercial rights outside certain Asian countries, may further accelerate this decline.
Regulatory Context
Poherdy (搜索)'s approval aligns with the FDA's recent initiatives to simplify the interchangeable biosimilar development process, designed to help patients and prescribers more easily identify low-cost alternatives to branded biologics. The interchangeable designation allows pharmacists to substitute Poherdy for Perjeta without prescriber intervention, similar to generic drug substitution practices.
This approval represents part of Organon's broader biosimilar portfolio expansion strategy, which also included acquiring rights to Biogen's Actemra (tocilizumab) biosimilar, Tofidence, in April 2025.