FDA News

FDA guidance recommends distinct names, suffixes for biosimilars

The FDA has released its final guidance for the naming of biological products, which recommends distinct names and suffixes for both biosimilars and reference products, according to a press release from the American College of Rheumatology.

“The American College of Rheumatology [ACR] has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substation, increase prescriber confidence and uptake of biosimilars, and ensure pharmacovigilance,” Angus Worthing, MD, FAP, chair of the ACR’s Government Affairs Committee, said in the release. “This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently and efficiently as possible.”

According to the release, the naming guidance is for both newly licensed and previously licensed biological products. An implication of guidance is that a pharmacist must ask the prescribing doctor for a new prescription before switching the patient to a new drug, if the biosimilar is not interchangeable. However, there was no guidance regarding suffix use in interchangeable products.

“The ACR supports the FDA’s recommendation of distinct suffixes for both biosimilars and reference biologics, so as to prevent prescribers from perceiving that drugs with suffixes are less safe or effective,” Worthing said. “One of our top priorities is to ensure that more affordable treatments reach our patients as quickly as possible, so we applaud the FDA’s measured and thoughtful approach to addressing provider confidence concerns while also prioritizing the safety of our patients.”

 

Reference:

www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/793/ACR-Applauds-FDA-Guidance-Requiring-Distinct-Names-and-Suffixes-for-Biosimilars-and-Reference-Biologics

The FDA has released its final guidance for the naming of biological products, which recommends distinct names and suffixes for both biosimilars and reference products, according to a press release from the American College of Rheumatology.

“The American College of Rheumatology [ACR] has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substation, increase prescriber confidence and uptake of biosimilars, and ensure pharmacovigilance,” Angus Worthing, MD, FAP, chair of the ACR’s Government Affairs Committee, said in the release. “This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently and efficiently as possible.”

According to the release, the naming guidance is for both newly licensed and previously licensed biological products. An implication of guidance is that a pharmacist must ask the prescribing doctor for a new prescription before switching the patient to a new drug, if the biosimilar is not interchangeable. However, there was no guidance regarding suffix use in interchangeable products.

“The ACR supports the FDA’s recommendation of distinct suffixes for both biosimilars and reference biologics, so as to prevent prescribers from perceiving that drugs with suffixes are less safe or effective,” Worthing said. “One of our top priorities is to ensure that more affordable treatments reach our patients as quickly as possible, so we applaud the FDA’s measured and thoughtful approach to addressing provider confidence concerns while also prioritizing the safety of our patients.”

 

Reference:

www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/793/ACR-Applauds-FDA-Guidance-Requiring-Distinct-Names-and-Suffixes-for-Biosimilars-and-Reference-Biologics