An overwhelming number of Australian physicians who prescribe biologics believe the TGA should insist on distinct non-proprietary scientific names for all biosimilars and reference products, a survey reveals.
However the 160 respondents of the online survey conducted by the Alliance for Safe Biologic Medicines (ASBM) were divided on whether biosimilars should receive an identifying prefix, suffix, or completely unique name.
Speaking at the official launch of the report Michael Reilly, Executive Director of ASBM said: “The discussion around naming, which is ongoing worldwide, is important as the majority of Australian physicians’ said that if two biologic medicines have the same name, they would infer that the medicines are identical, are able to be switched, and are approved for all the same indications”.
“As we know, this is not accurate for biologics, which are not identical and appropriateness of substitution is determined on a case by case basis.
The misunderstanding that is fostered by shared names raises potential safety concerns and presents difficulties with identifying the correct source of adverse events,” he said.
The full results of the survey, which involved rheumatologists, gastroenterologists, endocrinologists, dermatologists, oncologists, neurologists and nephrologists, are published here.
A spokesperson for the TGA reiterated that the WHO International Nonproprietary Names (INN) had proposed, but not yet adopted, the Biological Qualifier (BQ) scheme, which would apply a random four consonant code to all biological medicines.
While earlier this year the FDA released Nonproprietary Naming of Biological Products Guidance that suggested a suffix hyphenated after the active ingredient name of all biological medicines with retrospective effect.
“The suffix, though currently generated by the FDA, may be harmonised with the INN BQ, should the WHO adopt the scheme,” the spokesperson told the limbic.
The TGA is currently discussing its response to the BQ and FDA schemes with overseas regulators and is developing a public consultation paper.
“Until a final decision is made, the interim policy of naming biosimilars using the Australian Biological name of the reference product (without a specific biosimilar suffix) will continue,” the spokesperson said.