Wake Forest University to Conduct Observational Study on Age-Related Pain Incidence of Neulasta (Pegfilgrastim) in Breast Cancer Patients
Clinical Relevance of Neutropenia Prevention and Pain Management
Patients with non-metastatic breast cancer are at risk of developing neutropenia, a condition characterized by a rapid decrease in white blood cell count, during cytotoxic chemotherapy. To prevent this, granulocyte colony-stimulating factor (G-CSF) receptor agonists, such as Neulasta (pegfilgrastim) from Amgen (AMGN) or its biosimilars, are routinely prescribed. However, bone pain, a common side effect of Neulasta administration, significantly impacts patients' quality of life and adherence to cancer treatment. Therefore, identifying the demographic characteristics associated with these side effects and developing supportive care strategies to improve quality of life is a critical task for both the medical community and the pharmaceutical market.
Clarifying Age-Related Differences in Drug Side Effect Susceptibility
The NCT04174742 clinical study, led by Wake Forest University Health Sciences, aims to elucidate the age-related variations in pain associated with pegfilgrastim administration. Researchers are prospectively classifying patients into two cohorts: those aged 45 years or younger and those aged over 45 years. They are meticulously comparing the frequency and severity of self-reported pain in these cohorts. The Edmonton Symptom Assessment System (ESAS) score and the lowest absolute neutrophil count (Nadir ANC) at day 7 after administration are being tracked concurrently to determine the biological correlation with pain indicators. If statistically significant differences in age-related susceptibility are demonstrated, it could serve as a scientific milestone for establishing age-specific pain management protocols.
Market Shifts in Original and Biosimilar Products
The global pegfilgrastim market is estimated at approximately $3.7 billion in 2025 and is undergoing significant changes due to declining sales of the original drug, Neulasta, and the entry of competing biosimilars. Neulasta, once a blockbuster product for Amgen, has seen its sales decline sharply after patent expiration, with global revenues falling to approximately $848 million in 2023. In contrast, competing biosimilars, such as Fulphila from Viatris (VTRS), Udenyca from Coherus BioSciences (CHRS), and Nyvepria from Pfizer (PFE), are rapidly increasing their market share. In this market, securing patient-reported outcome (PRO) data is becoming a key competitive advantage for formulary listing and brand differentiation.
Evolution of Clinical Data Management and Personalized Medicine
This observational study, which began in December 2019, has now completed enrollment of the target number of patients (115) and is in an active, not recruiting phase, with data analysis and long-term observation underway. Final clinical completion is scheduled for January 2041, and long-term observation will continue to accumulate reliable follow-up clinical data on age-related side effect trends. The results of this study are expected to directly contribute to preventing early treatment discontinuation due to side effects and increasing the completion rate of cancer treatment. Ultimately, it is expected to accelerate the spread of personalized precision medicine and enhance the objectivity of adherence prediction for biosimilar prescriptions.
This study (NCT04174742) is the first long-term observational clinical trial to objectively demonstrate age-related differences in the side effects of Neulasta and biosimilars in the global pegfilgrastim market, which is estimated at approximately $3.7 billion in 2025. Original pharmaceutical company Amgen (AMGN) and biosimilar competitors such as Viatris (VTRS) can use this data to develop formulary acquisition strategies and patient adherence differentiation strategies, which will have a short-term impact on the marketing landscape. In the medium to long term, it is predicted that age-specific guidelines for neutropenia prevention will be established, reducing unnecessary cancer treatment discontinuation rates in clinical practice and redefining the standard for cancer supportive care. In particular, the self-reported pain data accumulated in this study, which is in the active, not recruiting phase, will be used by pharmaceutical companies as real-world evidence (RWE) and will serve as a key reference for future drug development and biosimilar introduction. As a result, the clinical data from this study will not only demonstrate the clinical value of the drug but will also become a key variable in determining the long-term market share of the product in the insurance and hospital bidding markets, which hold prescribing power.
Source: ClinicalTrials.gov (api_ct)