Biosimilars Approval to Biogenerics in Clinical Practice

Biological medicines are far more structurally complex and very sensitive to manufacturing conditions and thus harder to characterize and produce than small molecule drugs. Even minor changes in manufacturing may cause significant variations of the cellular systems used for biological production, also on differences within the structure, stability, or other quality aspects of the top product, all of which have the potential to affect tolerability and or efficacy and increase the danger of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there's some disagreement on which studies got to be implemented to approve a biosimilars. According to current literature, the subsequent points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to permit physicians to realize confidence in biosimilars.

  • Monoclonal antibody
  • Fusion protein
  • Biologic drug
  • Anti–tumor necrosis factor
  • Biotechnologic drug

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