By Anna Rose Welch, editor, Biosimilar Development
One technical expert from WHO outlined the current requirements for the two pathways for biosimilar prequalification and the progresses and pitfalls for companies seeking a spot on the WHO’s list of prequalified medicines.
By Ha Kung Wong and Erica L. Norey, Venable Fitzpatrick
Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offerings to the right audience at the right time.