This is the company's third biosimilar Biologics License Application in the United States.
After a lot of skirmish, Sandoz was finally able to launch the first-ever biosimilar product in the United States in September 2015—a good 6 months after being granted FDA approval. Now, the company, which is the generics wing of Novartis, has announced the filing of its Biologics License Application (BLA) for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim).
Neulasta, a pegylated form of recombinant human granulocyte colony-stimulating factor, is indicated to reduce the incidence of infection in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer agents. Neulasta was approved in 2002. Sandoz is seeking approval for the same indication as its reference product. The BLA includes results from 2 pivotal clinical trials: a drug distribution trial in health volunteers and 2 comparative efficacy trials and safety studies in breast cancer patients.
Sandoz is a leader in generic products and has a growing biosimilar pipeline, which includes products for blockbuster molecules adalimumab (Humira) and rituximab (Rituxan). The company recently filed a BLA for a biosimilar to etanercept, a TNF-alpha inhibitor marketed as Enbrel by Amgen.
“The FDA’s acceptance of our regulatory submission for biosimilar pegfilgrastim—our third biosimilar filed in the US—demonstrates our commitment to expanding patient access to biologics in the US,” said Mark McCamish, MD, PhD, who heads Global Biopharmaceutical & Oncology Injectables Development at Sandoz.
The discussion of course could boil down to cost, once approved. Will the biosimilar cost significantly lower than its reference product, which according to patient blog posts and the website GoodRx could be priced at anywhere between $3000 and $7000 for a single injection? Neulesta is recommended to be administered once per chemotherapy cycle in adults. What would make providers switch therapy and payers consider coverage for a biosimilar that may not have a significant cost advantage?
Zarxio, the biosimilar to Neupogen, is being sold at 15% lower price compared with the reference product.
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Many Patients With Psoriasis in Clinical Trials Experience Nocebo Effects, Study Finds
April 18th 2024Half of patients exposed to placebo in clinical trials experienced adverse events (AEs), which may be partially explainable by nocebo effects, according to a recent review and meta-analysis.
Read More
Low-Volume Hospitals Had Higher Reoperation Rate, Postoperative Complications in CRC
April 18th 2024Patients opting for elective colorectal surgery to address colorectal cancer (CRC) could have different rates of reoperation and postoperative complications based on the size of the hospital.
Read More