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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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
