article thumbnail

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. 1 (July 4, 2007): 61– 69, [link] 48 U.S. Even well-intentioned policies can create access disparities if communication and operational support are lacking.

article thumbnail

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog: Biosimilars

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

ICH Q6(R1): test criteria and specifications

European Pharmaceutical Review

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/214732/2007. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. 22 June 2017.

article thumbnail

Oncology biosimilar case studies: rituximab biosimilars

Pharmaceutical Technology

Rituxan’s success made it a prime target for biosimilar developers. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007. The first approved biosimilar in the US and EU was Celltrion/Teva Pharmaceutical’s Truxima/Blitzima in 2018 and 2017, respectively.

article thumbnail

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The post FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis appeared first on.

article thumbnail

Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. The post Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod appeared first on.

article thumbnail

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

Big Molecule Watch

RANIBIZUMAB MIDAS was deemed highly similar to Genentech’s LUCENTIS (ranibizumab), which was authorized in the EU on January 22, 2007. The post EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting appeared first on Big Molecule Watch.