Professor Wang Ting: HER2-Positive Breast Cancer Treatment Advances with the Launch of China's First Pertuzumab Biosimilar

Professor Wang Ting:HER2-positive breast cancer was once the subtype with the poorest prognosis among the four subtypes of breast cancer, characterized by a high risk of recurrence and metastasis and strong malignancy. However, with the advent of anti-HER2 targeted drugs, especially the widespread clinical use of monoclonal antibody drugs represented by trastuzumab, the treatment strategy for HER2-positive breast cancer has undergone a revolutionary change. Today, there is a wide variety of anti-HER2 drugs, including large-molecule monoclonal antibodies (such as pertuzumab, trastuzumab), small-molecule tyrosine kinase inhibitors (TKIs, such as lapatinib, pyrotinib, neratinib), and antibody-drug conjugates (ADCs, such as T-DM1, DS-8201). The emergence of these drugs has greatly improved the prognosis of patients with HER2-positive breast cancer, transforming it from the subtype with the worst treatment outcomes to one of the subtypes with the most significant survival benefits.。

However, in the clinical diagnosis and treatment process, there are still a series of challenges. The first challenge lies in the complexity of diagnosis, especially regarding the determination of HER2 expression levels. In clinical practice, we are accustomed to dividing HER2 status into positive and negative categories. However, in reality, HER2 expression levels represent a continuous variable ranging from low to high expression, and this boundary continues to expand as research deepens and technology advances. Therefore, re-establishing more scientific and accurate diagnostic criteria is crucial for precisely identifying which patients can benefit from anti-HER2 therapy in the future.

Secondly, drug resistance is also a major severe challenge faced currently. Although there are many anti-HER2 drugs available today, for patients with advanced breast cancer, tumor treatment still encounters the issue of drug resistance to current medications, thus necessitating continuous changes in therapeutic drugs. How to find a curative combination or regimen remains a direction that the medical community needs to strive to explore.

Moreover, the economic burden of treatment drugs on patients cannot be ignored in clinical practice. Although the extensive coverage of medical insurance policies and the active efforts of pharmaceutical companies have led to a continuous reduction in the prices of targeted drugs and ADC drugs, these treatment costs are still unaffordable for some patients. Therefore, how to reduce the economic burden of treatment while ensuring therapeutic efficacy and improving treatment outcomes remains an important challenge in clinical practice.

Finally, the survival rate of advanced breast cancer is also worthy of our high attention. Although a small number of patients with advanced HER2-positive breast cancer may achieve clinical cure, many patients will eventually face death. For those with refractory conditions, strong drug resistance, multiple systemic metastases, especially brain metastases that show poor response to anti-HER2 drug treatments, how we find more effective treatment methods to improve their quality of life and prolong survival is undoubtedly a key direction that needs our focus in future work.

Professor Wang Ting:The successful launch of Qilu Pharmaceutical's Pertuzumab biosimilar is an outstanding example in the field of biosimilar development. In China, several biosimilars have already been introduced and widely used in clinical practice. However, for Pertuzumab, a therapeutic drug, there has long been no biosimilar available in the Chinese market. The successful launch of Qilu Pharmaceutical's Pertuzumab biosimilar undoubtedly fills this gap, expanding treatment options for patients with HER2-positive breast cancer.

The Economic Accessibility of Pertuzumab Biosimilars Should Not Be Overlooked. Qilu Pharmaceutical's pertuzumab biosimilar not only enjoys the same reimbursement policy as the originator drug but has also launched a charitable drug donation program for self-paying patients, effectively reducing treatment costs for these patients and enabling them to afford related treatment expenses. For example, the originator pertuzumab is currently not reimbursed by medical insurance during the treatment phase for recurrent or metastatic breast cancer, which imposes a heavy financial burden on these advanced-stage patients. Eligible patients can apply for the charitable drug donation program for the pertuzumab biosimilar. Meanwhile, studies have shown that it demonstrates a high level of consistency with the originator drug in terms of efficacy and safety. Therefore, while lowering treatment costs, the therapeutic effects for patients remain well-assured. The emergence of Qilu Pharmaceutical's pertuzumab biosimilar, with its similar efficacy and safety, along with the concurrent charitable drug donation initiative, provides Chinese patients with an excellent alternative and a new option.

Moreover, the market entry of pertuzumab biosimilars has further accelerated the optimization and reshaping of treatment models. With the launch of this biosimilar, China now has a more comprehensive layout for commonly used treatment combinations involving anti-HER2-targeted large-molecule monoclonal antibodies. This development not only promotes diversified market competition but also injects new vitality into the entire industry. It expedites the optimization of treatment models, enabling patients to access more efficient, safer, and cost-effective treatment options.

At the same time, the development process of this biosimilar has also promoted the standardization and precision of clinical practice. The development of biosimilars is different from that of chemical drugs, and must strictly follow relevant norms and standards to ensure the scientific rigor of clinical trials and the consistency of results. The successful development of Qilu Pharmaceutical's Pertuzumab biosimilar has set a benchmark and model for the development of other biosimilars. Its Phase III clinical data also provides localized evidence support for the application of dual-target regimens in adjuvant, neoadjuvant, and advanced treatment, with extremely high clinical reference value. The launch of this Pertuzumab biosimilar not only stimulated the R&D capabilities of researchers in China but also enhanced the competitiveness of Chinese pharmaceutical companies in the global HER2-positive breast cancer treatment field. The emergence of this landmark achievement has enabled Chinese pharmaceutical companies to occupy a more important position on the international pharmaceutical stage, laying a solid and strong foundation for future global pharmaceutical market competition.。

Reviewed by Professor Wang Ting from Xijing Hospital, Air Force Medical University