Efficacy and Safety Study With MYL-1401H and Neulasta

Inclusion Criteria: * Signed and dated written informed consent. * Patients ≥18 years. * Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug. * Newly diagnosed, pathologically confirmed breast cancer. * Stage II or III breast cancer with adequate staging workup and adequate surgery if receiving adjuvant therapy. * Patients planned/eligible to receive neoadjuvant or adjuvant treatment with (Docetaxel, Doxorubicin, Cyclophosphamide \[TAC\]) for their breast cancer. * Cancer Chemotherapy and Radiotherapy naïve. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Absolute neutrophil count ≥ 1.5 × 109/L ; Platelet count ≥ 100 × 109/L ; * Hemoglobin \> 10 g/dL without blood transfusions or cytokine support during the two weeks previous to the hemoglobin level. * Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy. * Adequate renal function, i.e., creatinine \< 1.5 × upper limit of normal (ULN). Other protocol specific inclusion/exclusion criteria may apply Exclusion Criteria: * Participation in a clinical trial in which they received an investigational drug within 28 days before randomization. * Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastim forms on the market …