PBAC moves to reassure on biosimilars


white pills and tablets: GMiA

The PBAC has issued a statement intending to reassure the public about the safety of biosimilar copies of biologic drugs, in a bid to stamp out “misinformation” which could slow progress in biosimilars.

The PBAC recently recommended allowing biologics to be substituted with biosimilar drugs by clinicians and pharmacists if the biosimilar is found to be a safe and effective equivalent treatment.

The statement highlights the difference between biosimilar drugs and generic drugs (that generics are usually exactly the same as the original patented medicine).

“Because of both the complex nature of biologics and the way they are made, even though biosimilar drugs act in the same way as the original patented biologic, they may not be exactly the same,” the PBAC says. “However we would not [be] recommending them as substitutable with each other unless the PBAC is sure of their equal safety and effectiveness.”

The PBAC says it is important pharmaceutical companies earn a “fair return” on their investment in new drugs (ensured by the patent period).

“However, as with the introduction of generic drugs in the past, many expensive, high-use biologic drugs are coming off patent in the next five to 10 years in Australia and this presents an opportunity for other companies to produce these biologics which may make the drugs more affordable,” the PBAC says.

“The Australian Government and the PBAC are concerned that the introduction of biosimiliars may lead to the spread of misinformation, as has happened in other countries, which will slow the progress of the development of these medicines.”

It has placed advice on its website for concerned patients.

“According to PBAC guidelines, if the biosimilar is approved by the Therapeutic Goods Administration as a safe and equally effective treatment compared to another drug, the PBAC will then consider listing the biosimilar drug on the PBS,” says the PBAC.

“During this assessment process, the PBAC will also consider whether the biosimilar drug should be listed to allow substitution by a doctor or pharmacist. This will be done on a case by case basis.

“If the PBAC recommends the biosimilar should be substitutable this provides the option for clinicians and pharmacists to offer patients the choice of taking the original biologic drug or the substitute biosimilar drug, just as they currently do with generic versions of synthetic molecule drugs.

“The PBAC’s recommendation would, as always, give patients the ultimate choice as to which version of the drug they receive, again, just as they currently do with generic versions of synthetic molecule drugs.

“Also, clinicians would still have the ability to indicate a biologic drug is not to be substituted for a biosimilar for their patient if they do not consider it appropriate in that particular case (i.e. this just requires them to tick brand substitution not permitted on the prescription).

“This process is already familiar to clinicians as it is the current process for generic versions of synthetic molecule drugs.”

PBAC plans to meet with stakeholders to consult on the application of this recommendation to provide feedback to the committee on how the initiative could successfully apply in practice.

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