Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) have announced that the U.S. FDA has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab‑dpzb) 420 mg/14 mL injection for intravenous administration. This interchangeable biosimilar to PERJETA (pertuzumab) is approved for all indications of the reference product. POHERDY becomes the first and only pertuzumab biosimilar authorized in the U.S., marking a key advancement in improving patient access to high-quality and potentially more affordable biologic treatments for certain HER2-positive breast cancers.
POHERDY is indicated for use in adults with HER2‑positive breast cancer both metastatic (in combination with trastuzumab and docetaxel) and early-stage disease (as neoadjuvant or adjuvant therapy in combination with trastuzumab and chemotherapy). The approval was granted after reviewing a comprehensive data package demonstrating that POHERDY is highly similar to the reference product in safety, purity, and potency.
This milestone is significant: as a biosimilar, POHERDY has potential to improve access and affordability of anti-HER2 therapy, an important consideration for global oncology care strategies.
However, prescribers must remain aware of safety considerations associated with pertuzumab products, including potential cardiac risks (decreased left ventricular ejection fraction, risk of heart failure) and embryo‑fetal toxicity; appropriate cardiac monitoring and contraceptive advice are recommended.
Discover comprehensive insights on HER2-Positive Breast Cancer market trends, analyze epidemiology, market trends, and competitive landscape to guide strategic decisions through 2034.
How DelveInsight Reports Add Value
DelveInsight is a well‑established market research and consulting firm providing in‑depth reports across therapeutic areas including oncology and gene therapy. Their reports combine epidemiology data, market sizing and forecasts, competitive landscape, pipeline analysis, and regulatory context offering clients a comprehensive view of the current and future market scenario.
For instance, their oncology‑based reports cover historical and projected disease epidemiology, patient segmentation by age/gender/geography, drug uptake trends, and competitive positioning.
In the context of POHERDY’s approval, a DelveInsight oncology market report could help pharmaceutical companies, payers, and investors by:
- Estimating the potential addressable patient population (HER2-positive breast cancer) across major markets.
- Forecasting market uptake of POHERDY and competing therapies over the next 5–10 years.
- Analysing pricing, reimbursement, and access scenarios – especially given its biosimilar status.
- Identifying competitive dynamics, including how originator biologics and other biosimilars might respond post‑approval.
- Guiding strategic planning (manufacturing, launch timing, partnerships) based on epidemiology trends and market demand.
Such data-driven intelligence is particularly valuable in oncology, where disease prevalence, treatment guidelines, and reimbursement frameworks are constantly evolving.
Conclusion:
The FDA approval of POHERDY represents a meaningful advancement in the treatment landscape for HER2‑positive breast cancer offering a biosimilar option that may improve accessibility without compromising efficacy. Meanwhile, leveraging a dedicated market‑intelligence resource such as DelveInsight’s reports can offer stakeholders from pharma companies to payers a grounded understanding of market potential, competitive dynamics, and strategic opportunities. Together, regulatory progress and robust market insight help bridge the gap between clinical innovation and real-world impact.
