Biosimilars guidance updated for hospitals

The Council of Therapeutic Advisory Groups (CATAG) has highlighted the importance of accurate and consistent communication about biosimilars across all  areas of patient care.

In an update of their Guiding principles for the governance of biological and biosimilar medicines in Australian hospitals, CATAG recommended that biologics and biosimilars are always described by both their active ingredient and trade name.

This includes in medication histories, discharge summaries, medication lists, medication reconciliation documentation and medication charts.

Clinical pharmacist and CATAG coordinator Jane Donnelly said previous guiding principles had only focused on communication around the prescription of biologics and biosimilars.

“There is the potential for variability between biosimilars so it’s important we’re not switching back and forth unless it is a deliberate switch with the consent of all parties.”

As well as its importance for patient outcomes, improved communication and documentation of biosimilars will help improve traceability as part of rigorous pharmacovigilance, she said.

The guidance has also been updated with regards to substitution of a biologic with biosimilars, reflecting national and international developments including the outcome of the TGA review.

“Substitutions can occur where biologics have been assessed by a DTC, determined to be interchangable and form part of a DTC approved treatment protocol that allows substitution at dispensing. The DTC should consult with the relevant prescribers when developing the treatment protocol” it says.

However gastroenterologist Associate Professor Susan Connor from Liverpool Hospital said specialists should not accept brand substitution.

“There is no evidence to say that repeated substitution is safe, at least in the context of IBD. The evidence at the moment says one switch is okay,” she said.

She said three biosimilars for infliximab would be available in early 2017.

While she hoped hospital drug committees would make decisions based on evidence, there was also likely to be financial pressures to use the most cost-effective brand.

“We welcome biosimilars coming into the market to lower the price of incredibly effective drugs for patients with IBD. However we want the biosimilars to not only be cost-effective but effective and safe.”

“Drug committees can make overarching statements about biosimilars and bioequivalence but in the context of patient centred care, treatment decisions have to be based on the patients’ individual needs including their history, reactions to previous drugs, etc,” she said.


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