New Biosimilar to Neulasta Approved
On May 7, 2026, the US Food and Drug Administration (FDA) approved Ennumo™ (pegfilgrastim-pccg) injection, Accord BioPharma’s biosimilar to Amgen’s Neulasta® (pegfilgrastim). Ennumo is indicated in adults and pediatric patients from birth and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients who have non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome). The biosimilar was approved for the same indications as Neulasta. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog filgrastim, which prolongs its duration of action. G-CSF stimulates the bone marrow to produce neutrophils, helping to reduce the risk of infection in patients experiencing chemotherapy-induced neutropenia. Other Neulasta biosimilars include Fulphila® (pegfilgrastim-jmdb – Mylan/Biocon), Nyvepria™ (pegfilgrastim-apgf – Pfizer), Udenyca® (pegfilgrastim-cbqv – Coherus BioSciences), Ziextenzo® (pegfilgrastim-bmez – Sandoz), Fylnetra® (pegfilgrastim-pbbk – Amneal Pharmaceuticals), Stimufend® (pegfilgrastim-fpgk – Fresenius Kabi) and Armlupeg™ (pegfilgrastim-unne – Lupin). As with other pegfilgrastim biosimilars, Ennumo is not designated as interchangeable with Neulasta or with other pegfilgrastim biosimilars. Ennumo will be supplied as a 6mg/0.6mL single-dose prefilled syringe for subcutaneous (SC) injection. Launch date is currently unknown. Pegfilgrastim products generated $3.1 billion in US sales in 2025.
Wilate Approved for Younger Children
On July 2, 2026, the FDA approved Wilate® [von Willebrand factor/coagulation factor VIII complex (human) – Octapharma] for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients younger than six years of age who have von Willebrand disease (VWD). It is now indicated for routine prophylaxis for all adults and children with all forms of VWD. Previously, it was approved for patients six years of age and older. According to the Centers for Disease Control and Prevention (CDC), VWD affects about 3.4 million Americans; however, only about 340,000 of these patients develop symptoms. VWD is an inherited blood clotting disorder that occurs in females and males equally, but women are more likely to have symptomatic disease. It is caused by a deficiency or dysfunction of von Willebrand factor, a protein needed for normal blood clotting, and may result in frequent nosebleeds, easy bruising, excessive bleeding after injury or surgery, and, in severe cases, spontaneous bleeding episodes. The expanded approval was supported by results from the phase III WIL-33 trial, which evaluated Wilate prophylaxis in 12 children younger than six years of age with severe VWD. The study demonstrated a low annualized bleeding rate of 4.6, with 98.2% of bleeding episodes classified as minor. Among treated bleeding episodes, 95.6% were controlled with a single infusion. For routine prophylaxis in children younger than six years with VWD, the recommended dose is 30 IU/kg to 50 IU/kg administered as an intravenous (IV) infusion two or three times weekly, with the dose and frequency individualized based on the patient’s clinical response. Wilate is also approved to treat and prevent bleeding episodes in patients 12 years of age and older who have hemophilia A. Here is its updated prescribing information.
Keytruda Combo Broadens Bladder Cancer Approval
On July 10, 2026, the FDA approved Merck’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Pfizer and Astellas Pharma’s Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients who have muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility. Keytruda is a programmed death receptor-1 (PD-1) inhibitor that reactivates T-cell immune response, while Padcev is an antibody-drug conjugate targeting Nectin-4 to deliver a cytotoxic payload directly to tumor cells. The broadened indication builds on the November 2025 approval, which was limited to cisplatin-ineligible patients. MIBC is an aggressive cancer in which tumors penetrate the bladder muscle, increasing the risk of metastasis. Standard treatment involves removal of the bladder, often combined with cisplatin-based chemotherapy, but up to 50% of patients are ineligible due to kidney or comorbid conditions. Without systemic therapy, recurrence and mortality rates remain high. Approval was based on the phase III KEYNOTE-B15/EV-304 trial in cisplatin-eligible patients, which demonstrated a 47% reduction in the risk of tumor recurrence, progression or death compared with neoadjuvant gemcitabine and cisplatin, with an estimated 79.4% of patients event-free at two years compared to 66.2% with chemotherapy. A 35% reduction in the risk of death was also observed and the pathological complete response rate at the time of surgery was 55.8% with the combination compared with 32.5% with chemotherapy. The recommended dose in cisplatin-eligible patients during the neoadjuvant phase consists of four 21-day cycles of Padcev 1.25mg/kg intravenously (IV) on days one and eight plus Keytruda 200mg IV every three weeks or 400mg IV every six weeks. Following cystectomy, five additional cycles of Padcev are given with Keytruda at the same schedule for 15 weeks, followed by Keytruda monotherapy to complete 39 weeks of adjuvant therapy. Padcev carries a boxed warning for severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Full prescribing information is available here for Keytruda, here for Keytruda Qlex, and here for Padcev.
FDA Approves Subcutaneous Formulation of Sarclisa for Multiple Myeloma
On July 10, 2026, the FDA approved Sarclisa Escena® (isatuximab-irfc – Sanofi), a new SC formulation for the treatment of adults who have multiple myeloma (MM) across all previously approved indications of the IV formulation. Sarclisa is a CD38-directed monoclonal antibody indicated for use in multiple treatment settings, including newly diagnosed patients who are not candidates for autologous stem cell transplant (ASCT), patients with relapsed or refractory disease following one to three prior therapies, and those who have received at least two prior lines of treatment, in combination with established myeloma regimens. The recommended dose is 1,400mg administered SC, either through the CirCLIQ® on-body injector (OBI) or by manual injection by a healthcare provider. Treatment is given weekly during the first cycle and every two weeks thereafter as part of the applicable combination regimen. Sarclisa Escena is expected to become available in the United States in the coming weeks. While not yet available, the updated prescribing information will be found here.