Though later than expected, yesterday’s publication of draft guidelines on the interchangeability of a biosimilar with its reference product by the US Food and Drug Administration (FDA) have been applauded by drugmakers.
Pfenex described the FDA guidelines as “an important step in creating a robust market for biosimilars in the United States” in a statement sent to Biopharma-Reporter.
“This recommendation, which directs a biosimilar developer to submit data from a switching study in order to demonstrate interchangeability, signals the FDA’s support for the safety and efficacy of a biosimilar compared to a reference product.”
Essential pathway
Yesterday’s publication called for a switching study (or studies) to demonstrate the risk in terms of safety or diminished efficacy of alternating between a biosimilar and its reference product is not greater than the risk of using the reference product without such switch.
Pfenex said the FDA has now provided developers with “a pathway to demonstrate interchangeability” and such Agency support “is essential to supporting this construct, reducing physician and pharmacist confusion and encouraging a greater number of biosimilars developers to enter the market.”
Meanwhile Pfizer – with its Remicade (infliximab) biosimilar Inflectra already available in the US, albeit not yet interchangeable – told us it “appreciates the Agency’s efforts to clarify the regulatory standard for interchangeability of biological products.”
According to spokeswoman Rachel Hooper, “it is Pfizer’s position that only when FDA has designated a biological product as interchangeable and state law allows for the substitution of such an interchangeable biological product, an interchangeable biological product may substituted by a pharmacist and that physicians should be informed and patients consulted.”
Review period
She added: “Pfizer is working to review and evaluate the FDA’s draft guidance.”
As are Novartis subsidiary Sandoz and Amgen, both of which have had biosimilars approved in the US.
Spokesman Duncan Cantor said Sandoz is “pleased that the FDA has issued draft guidance on the important topic of interchangeability,” but did not offer up comment as his firm is currently reviewing the guidance.
Sandoz’ Zarxio – a version of Amgen’s Neupogen (filgrastim) – was the first biosimilar product to be approved in the US in September 2015, while Erelzi – its version of Amgen’s Enbrel (etanercept) – was approved by the FDA last August. Neither products have been deemed interchangeable for now.
Amgen – which saw Amjevita, its version of AbbVie’s Humira (adalimumab), approved last September – also had no statement at this time as it undergoes a review of the “fairly dense” guidance.
Industry has 59 days to submit comments on the proposed recommendations to the FDA. A final guidance is expected to be published later this year.