As patents expire on some of the world’s most expensive biologic medicines and biosimilar competitors seek market entry, a new discussion has emerged in Australia about how these products should be named. Some argue that as biosimilar medicines are not ‘identical’ to the original reference product, active ingredient names with unique identifiers such as suffixes or prefixes are required to enable accurate tracing of medicines for the purpose of pharmacovigilance, specifically the reporting of adverse events. This position is based on the assumption that the current system for reporting adverse events is somehow not appropriate for biosimilar medicines.
But is there a problem? Is there any rationale to treat biosimilar medicines any differently to other medicines? And do we think changing the way we name biologic medicines will fix the problem? To answer these questions, we need to take a look at how the TGA assesses and monitors medicines.
TGA assesses risk of all medicines prior to granting marketing authorisation
The TGA adopts a risk-benefit approach to the regulation of ALL medicines taking into account the medicine’s safety profile, efficacy, indication and target population. These characteristics are specific to the medicine itself and not to whether the medicine is derived from natural sources, chemical synthesis or through biologic processes.
The TGA has a three-step approach to medicines regulation, starting with pre-marketing evaluation, licensing of manufacturers, and continuing with post-marketing surveillance. Post-marketing surveillance of medicines is vital as it provides real world evidence of a medicine’s safety and efficacy, adding to the substantial data already obtained through clinical trials and publicly disclosed in the Product Information.
Risk assessment doesn’t stop once a medicine is marketed
Medicines sponsors have a key role in post-marketing surveillance and the requirements for sponsors of biosimilar medicines are no different to those for any other prescription medicine.
Sponsors of ALL medicines are required to have an effective adverse event recording and evaluation system in place so any post-marketing signals likely to impact on the risk benefit profile of a medicine are effectively detected, analysed and communicated to the TGA, prescribers and consumers. It is mandatory for sponsors to report any information likely to significantly impact on the risk benefit (that is any significant change to the safety or efficacy) profile of the medicine.
A Risk Management Plan is required to be submitted for ALL new prescription medicines and new indications likely to significantly impact on the currently established risk benefit profile of the medicine. And, all sponsors must submit regular Periodic Safety Update Reports to the TGA for several years after registration of a new medicine.
Spontaneous reporting of adverse events provides additional information
Adverse events happen. And sometimes, the incidence of adverse events in the real world can be different to what is observed in clinical trials. When an adverse event is suspected, healthcare professionals and consumers are encouraged to make a spontaneous adverse event report to both the sponsor and the TGA. The information provided helps sponsors and the TGA identify risk, and can result in a range of actions by the sponsor from an update to the medicine’s Product Information and Consumer Medicine Information, to a national recall.
Enhance what is already in place
The current process for reporting adverse events is well established. We need to remind everyone that the current TGA online system for reporting an adverse event encourages the completion of a number of fields for data entry, including the brand name, active ingredient name, batch number, AUST-R or AUST-L number, and expiry date. Similar data are required by sponsors when processing adverse event contacts made directly to them. In parallel, education and encouragement for healthcare professionals and consumers on how to report an adverse event, and why it’s so important, is also needed.
Unique names won’t improve reporting
If the problem some think we have is that we need a unique name to track biosimilar medicines, then we are missing the point. All medicines supplied in Australia already have a number of unique identifiers – including the brand name, active ingredient, batch number and expiry date. It would be impossible not to be able to identify a medicine suspected of causing an adverse event if all four of these identifiers are reported.
There is no rationale for treating the post-marketing surveillance of biosimilar medicines any differently to other prescription medicines. If we are genuine about observing biologic and biosimilar medicines in the real world, encouraging the proper reporting of adverse events is a much better solution than applying different names or adding another meaningless, unique identifier.
Belinda Wood is the CEO of GBMA.
April 2017