La European Generic and Biosimilar Medicines Association (EGA) has welcomed the approval of the first biosimilar medicine by the United States Food and Drug Administration (FDA) on March 06. It should be noted that the biosimilar Zarxio, from Sandoz, whose reference product is Neupogen (filgrastim), is approved for the same indications as the reference drug. This approval is another important milestone for patients after the launch at the European level of the first biosimilar monoclonal antibody, infliximab. Since 2006, the biosimilar drugs approved by the EU have generated more than 400 million patient-days of clinical experience.
Un biosimilar drug is a biological medicine that is being developed to be very similar to an existing biological medicine (the reference medicine). The company has to demonstrate that the biosimilar medicine has no significant differences from the reference medicine in terms of quality, safety or efficacy. In Europe, regulatory authorities assign the same International Nonproprietary Name (INN) for biosimilar medicines as their reference products. Since 2006, this policy supports the safe use of biosimilar medicines in more than 60 countries around the world.
To maintain scientific consistency and to avoid confusion among stakeholders regarding the same biosimilar medicine, the EGA has requested that the FDA adopt the same policy using the INN for biosimilar medicines as the European Medicines Agency (EMA). . Clear identification of biologics for prescription, dispensing, and track and trace purposes would be ensured through the brand name. The EGA believes that the unique product brand name is the best unique identifier for patients and healthcare professionals.
"The approval of the first biosimilar drug by the FDA is another key milestone in improving patient access to biologic medicines,” said Adrian van den Hoven, EGA Director General. “The next step will be to adapt the policy of the EU and the US, assigning the same INN name for the same biosimilar product in the markets based on the 10 years of clear and positive experience of the EU”, he concluded.
