Biosimilar Global Reference Standard Intrigues US FDA, But Many Questions Still To Answer
Scientific and legal issues still must be resolved before establishing single reference products for biosimilar development, US FDA official says.
You may also be interested in...
Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
Agreement with AbbVie allows Amgen to launch its Humira biosimilar in Europe in 2018 and in the US in 2023; it may be akin to generic settlements but it is uncertain if other sponsors will get similar deals.
The amount of exclusivity remaining for a reference product, strength of an innovator's patents and risk of a preliminary injunction are factors that biosimilar sponsors should consider in deciding whether to follow the BPCIA's patent information and exchange procedures, one legal expert suggests.