CapeOX (capecitabine and oxaliplatin) combined with sintilimab and bevacizumab biosimilar (IBI305) for first-line treatment of advanced gastric or oesophagogastric junction adenocarcinoma: study protocol for a single-arm, phase Ib/II trial. [PDF]
BMJ OpenDai R +5 more
europepmc +1 more source
Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies. [PDF]
Pharmaceuticals (Basel)Niazi SK.
europepmc +1 more source
The Impact of U.S. Tariffs on the Pharmaceutical Industry and Medicine Access in Europe: Challenges, Opportunities, and Future Outlook. [PDF]
Hosp PharmCastellana E, Chiappetta MR.
europepmc +1 more source
Immune checkpoint inhibitor-based first-line therapies for advanced or unresectable hepatocellular carcinoma: a network meta-analysis and cost-effectiveness analysis. [PDF]
Ther Adv Med OncolQi H +8 more
europepmc +1 more source
Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open-Label, Parallel-Group Study. [PDF]
Clin Pharmacol Drug DevChow V +8 more
europepmc +1 more source
Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges. [PDF]
Pharmaceuticals (Basel)Bas TG.
europepmc +1 more source
Biologic Drug Prices in Medicare Part B After Entry of Biosimilars to the Market.
JAMA Netw OpenAbdelaziz A +3 more
europepmc +1 more source
Biosimilar insulins: Narrative review of the regulatory framework and registration studies. [PDF]
Diabetes Obes MetabHeise T, DeVries JH.
europepmc +1 more source
A Randomized Phase 1 Study Comparing the PK, PD, Safety, and Immunogenicity of Proposed Biosimilar RGB-14-X and Denosumab in Healthy Adult Males. [PDF]
Clin Transl SciBiver E +11 more
europepmc +1 more source