Holz, MD, discussed the rationale and safety surrounding the automatic substitution of biosimilars at the pharmacy level, as well as common misconceptions about these medications.

Most states permit the substitution of a reference product for an interchangeable biosimilar without the approval of the prescribing physician. The time frame required for communication to the ...

The approval for interchangeability was supported by data from a phase 4 trial that assessed the pharmacokinetics, efficacy, safety, and immunogenicity of Hadlima vs Humira in patients with moderate ...

A biosimilar with interchangeability is not ... year if the bill is passed into law to complete a study evaluating how substitution of interchangeable biologic products may be impeded.

The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was ...

Unlike generics, biosimilars are not necessarily designated as fully interchangeable, meaning that only the prescriber, not pharmacists, can substitute a biosimilar for the reference product ...

“To the extent that we see biosimilar substitution and formulary status moving in this direction, that will encourage companies to develop biosimilars,” she said.

Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the ...

These distinctions may necessitate specialized analyses for identification. The push for enforced substitution of biologics with biosimilars has ignited a contentious debate. Health insurance ...

The company has obtained the FDA's interchangeability status for the biosimilar, which means pharmacists can substitute it for Stelara without the advice of a healthcare professional. Evernorth ...

as there is a misconception that interchangeable biosimilars are superior to those without the designation – when it really means that depending on state laws a pharmacist-level substitution ...