Biobetters Vs Biosimilars

Biosimilars differ from generic drugs by their characteristics, their raw materials and manufacturing processes. Differences between generics and biosimilars focus on product development, marketing authorization, and post-registration monitoring. There are essential differences between the two regulatory pathways relating to biosimilars. Unlike generic medicines, where the active ingredients are identical, biosimilars, by definition, are not likely to be identical to the originator biologic. They are similar, but not the same

The case of “biobetters” illustrates a product differentiation strategy comparable to what we see with supergenerics and hybrid products, and is likely to bring a new dynamic of competition to the market.  These products can also improve patient access to more affordable innovative products. In turn, the whole concept of a new pharmaceutical product is evolving.

  • The future of biosimilars in specific emerging markets
  • Safety in biosimilar development
  • Methods for biobetter development
  • Marketing Biosimilars in the EU
  • What impact does a modified immunological profile have on the clinical outcome?
  • Importance of Phase III immunological trials, analytical expertise
  • Ultra potent antibodies and ligand traps
  • Glycoengineering to increase potency
  • Clinical approach and safety in biosimilar development
  • Pharmacokinetic studies of approved biosimilars

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