EU Industry Groups Urge Caution on Biosimilar Switching

Regulatory News

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:

1. “When the initial treatment choice, e.g. reference product or biosimilar, loses efficacy or when there are tolerability issues, switching to a similar product within the same group of related products”
2. “If the physician feels that on balance a switch is likely to compromise future treatment options for the patient, (e.g. with an alternate biological therapy), then a switch is not advisable.”

Position Paper