Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.
One-year results of a phase 3 study of a proposed ranibizumab biosimilar (SB11) in patients with neovascular age-related macular degeneration have shown equivalence in efficacy and pharmacokinetics (PK), as well as comparable safety and immunogenicity to the reference product, according to Samsung Bioepis.
Results of the study will be presented at the American Academy of Ophthalmology 2020 Virtual meeting from November 13 to 15, 2020.
Investigators enrolled 705 patients and said that 634 patients completed the study up to week 52. They said that clinical end points, defined as changes from baseline in best corrected visual acuity (BCVA) at week 8 and central subfield thickness (CST) at week 4, were met.
Long-term efficacy, safety, PK, and immunogenicity were secondary end points, and findings were comparable between SB11 and the reference product (Lucentis).
In the randomized, double-blind, multicenter study, the 8-week mean change in eye chart letters read correctly from baseline in BCVA at week 8 was –0.8 letters (90% CI, –1.8 to 0.2) between SB11 and reference ranibizumab. The mean change from CST baseline at week 4 was an adjusted treatment difference of −8 mcm (95% CI, −19 to 3 mcm) between SB11 and the reference agent.
The mean change from baseline in BCVA by week 52 was 9.79 letters for SB11 vs 10.41 letters for reference ranibizumab (difference: –0.62 [90% CI, −2.092 to 0.857]).
The mean change in CST was −139.55 mcm for SB11 compared with −124.46 mcm for reference ranibizumab (difference: −15.09 [95% CI, −25.617 to −4.563 mcm]).
Investigators said that PK, safety, and immunogenicity between the biosimilar candidate and reference product were comparable at all time points up to week 52.
In May 2020, Samsung Bioepis reported 24-week interim results from the same study.
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.
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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.