EMA

For Inflectra launch, Pfizer uses 'hybrid model' to home in on HCPs Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson's Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—wh...

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally. On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Produc...