2007 Biosimilars Labelling 
Putting Patients First Blog
JUNE 26, 2025
CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. Goldman, Geoffrey F.
pharmaphorum
SEPTEMBER 20, 2021
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.
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pharmaphorum
AUGUST 3, 2022
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.
European Pharmaceutical Review
DECEMBER 20, 2023
Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) By contrast, orphan drugs could become less profitable, more risky investments.
FDA Law Blog: Biosimilars
APRIL 30, 2023
Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions. 112-144 (2012).
Putting Patients First Blog
JANUARY 27, 2025
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Increased transparency will ensure that formulary practices align with broader goals of affordability and patient access.
FDA Law Blog: Biosimilars
MAY 11, 2023
GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”
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