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Novartis: New Study on Pegfilgrastim Biosimilar Requested by FDA
Sandoz received a complete response letter from the US Food and Drug Administration (FDA) in regard to its pegfilgrastim biosimilar application, filed in 2015.
As reported in July, Sandoz received a complete response letter from the US Food and Drug Administration (FDA) in regard to its pegfilgrastim biosimilar application, filed in 2015. On its third-quarter earnings call, Novartis provided further hints at the reason for FDA’s rejection of this biosimilar. Apparently, further data are required.
Novartis’ Sandoz unit has several additional biosimilar assets, including its marketed filgrastim-sndz product Zarxio, its recently approved biosimilar to Enbrel, and its investigational infliximab biosimilar (purchased from Pfizer after that company’s acquisition of Hospira).
Vasant Narasimhan, MD, Novartis’ Global Head of Drug Development and Chief Medical Officer, confirmed, “As noted in the second quarter, we did receive a complete response letter and are continuing to engage in discussions with those at FDA and with EMA. In the US, we have agreed with the FDA to move forward on an additional study to address their data request. We would expect to submit that study to the FDA in 2018.”
In other news… The biosimilar partnership between Momenta Pharmaceuticals and Mylan took another step recently, when they announced the commencement of its phase 1 study of M834, a biosimilar of abatacept (Orencia). This investigation, slated to end June 2017, will evaluate the pharmacokinetics, safety, and immunogenicity of this biosimilar in comparison with both the US and EU-licensed versions of Orencia in healthy volunteers. This is the first of 6 biosimilars in the Momenta—Mylan partnership to reach the clinical trial stage.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
