Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for ...

Most consumers are fine with laptop batteries allowing for a few hours of use. Is there a possibility for laptop batteries to ...

Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. FDA justified its ...

1. When a biosimilar gets an “interchangeable” designation, the therapy may be substituted for the biologic without the involvement of a prescriber, similar to how generics are substituted for ...

Biologics have revolutionized the management of immune-mediated inflammatory diseases (IMIDs). Biosimilars are biologics that exhibit no significant differences in safety or efficacy compared with ...

There has been a mixed response to the US Food and Drug Administration’s (FDA) recent draft guidance update stating that clinical switching studies are generally not necessary to demonstrate that a ...

President Joe Biden’s budget proposal for fiscal 2025 includes a proposal that would allow pharmacy substitution of biosimilar drugs for the reference product, even if they are not designated as ...

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...

A panel of experts discuss future opportunities with interchangeable biosimilars from payer and provider perspectives. Ryan Haumschild, PharmD, MS, MBA: Thanks to all of you, my experts, for this rich ...