Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

This is a good summary of the insulin regulatory mess: https://t.co/VcXIxXNOvC

@Biomaven @XBIObserver This is a “good” summary of the mess that is regulation (particularly lack of substitutable generics) of insulin. It’s horrific. https://t.co/VcXIxXNOvC

@seba1337 @barhri @naravoslovec Ni bil biološko zdravilo, v regulatornem smislu, kar pomeni, da “generika” niso mogli registrirati preko biosimilars postopka, temveč le preko bioekvivalence, kar pa je bilo težje, neekonomično in trg je bil zasičen... Že

@seba1337 @naravoslovec Short answer: FDA je recently spremenila odobritveni postopek. Ta nekdo, da vlogo za odobritev biosimilarja, v kateri mora dokazati, da je njegov “generični” inzulin strukturno podoben originatorjevemu. Fin vir: https://t.co/VyTk3X