Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 09 March 2017 | By Zachary Brennan
Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday.
While noting a lack of regulatory requirements for individually approved biosimilars to the same reference product to be compared with each other, the trio note: “Switching between biosimilars represents an unknown, and one that harbours considerable uncertainty.”
Dr. Duncan Emerton, a UK-based biosimilars expert, explained to Focus that although there is not a regulatory requirement to compare two or more biosimilars to one another, “When EMA [the European Medicines Agency] approves multiple biosimilars to the same reference product, they do using the same standard…One would expect both biosimilars to deliver the same clinical outcome.”
And because each new batch of a biologic is a different product, switching a patient between biosimilars for the same reference product is “no more risky” than switching a patient from the reference product to one of the biosimilars, Emerton noted.
The European Federation of Pharmaceutical Industries and Associations, International Federation of Pharmaceutical Manufacturers & Associations and European Biopharmaceutical Enterprises also note in the paper the “complex nature of biological molecules, which are often used to treat patients who have multifaceted, chronic diseases,” meaning any decision to switch to a biosimilar or to a reference product “should be made on a case-by-case basis and must be patient-, disease- and product-specific.”
The three industry groups, whose member companies stand to lose billions in brand name product revenues when more biosimilars are approved, also point to two scenarios when switching from a reference product to a biosimilar or vice versa is not recommended:
Tags: biosimilars, biosimilar switching, regulatory requirements biosimilars
Regulatory Focus newsletters
All the biggest regulatory news and happenings.