Debate in the biopharma industry revolves around whether biosimilars should share an International Non-proprietary Name (INN) with their reference biologic and with other biosimilars.
Virginia Acha, a member of IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and Director of Regulatory Affairs at Amgen UK, told us at DIA Euromeeting this week IFPMA and Amgen “would like to see a biologic qualifier applied to all biotherapeutics.”
However she denied this proposal amounted to changing a biologic’s INN and insisted naming standards for the non-proprietary label itself would not be affected.
EGA: ‘increased confusion’
A biologic qualifier combined with the INN would help product identification and patient safety, Acha said.
“I would be able to trace anywhere in the world where a product has been involved in an adverse event. This is important for product safety and pharmacovigilance globally because we are increasingly an interconnected and global healthcare system, so we need to understand that the signal we identify in one location can be quickly identified elsewhere.”
The advantage of a biologic qualifier, said Acha, is that “it gives you both product level identification and retains the INN naming system in a good way.”
Other groups do not share Amgen’s stance. In January, the European Generics Association (EGA) told BioPharma-Reporter.com different names for biosimilars would be “very likely to increase confusion.”
EGA’s senior director of scientific affairs, Suzette Kox, said it was important to remember “the INN only identifies the active substance, not the finished drug product. It was never intended to be a unique tool for traceability; this has been fully recognized by the EU regulators.”
‘Weird product’ labels
According to the IFPMA’s proposal, the addition of a qualifier should be “non-discriminatory,” “so it shouldn’t label anything out as ‘weird product over here’, ‘originator over there,’” said Acha.
The programme would be run “hand-in-glove between the WHO and the national regulatory authorities,” with naming negotiated at the same time a company submits marketing authorisation for a product.
How exactly the biologic qualifier is comprised is “under review,” Amgen told us, giving the hypothetical example of trastuzumab, the non-comparator name of breast cancer biotherapy Herceptin.
“If you had a biologic qualifier, depending on how it was generated, it could be [called] ‘trastuzumab-AMG’ for Amgen if and when ours gets to the market. Or ‘trastuzumab –ABCD’.
“You would know that ‘trastuzumab–ABCD’ is linked to Amgen and therefore Amgen has to solve any problems.” Conversely, she said, if a particular adverse issue is found to be a class-level effect, it would be simple to identify by name all trastuzumab biologics as causes for concern.
Acha pointed to the example of the anaemia biologic epoitin alfa, which in 2007 was linked to serious illness in some patients in Thailand because of problems with the syringe stoppers of some of its biosimilars. Since local pharmacists had prescribed various epoitin alfa biosimilars without full documentation, it was impossible to determine who had taken which version of the drug.
To prevent similar future crises, the proposed naming changes would need to be combined with greater engagement from healthcare professionals who must keep better records, Acha added.
With some clinics worldwide using electronic records of what drugs patients take, and others paper-based documentation, there are very few studies on the quality of day-to-day record-keeping, said Amgen’s regulatory expert. Yet clear, up-to-date notes would be vital to the traceability of biosimilars, so “you have a means to identify a product based on its name but you also have the practice in place to make sure it’s recorded.
“That’s the thing that even regulators struggle with – they can’t make people do things. They can put up the policies, but what happens in the hospital and patient records, that’s the part of the puzzle that we need to spend a little more time understanding. If we do that we’ll be on to world peace after that.”