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Evaluation of biosimilars
Pharmacovigilance of biosimilars
As clinical trial data are usually insufficient to identify rare adverse effects, the general pharmacovigilance requirements applied to biosimilars are the same as those for any biological medicine. The sponsor must develop a comprehensive Risk Management Plan outlining the pharmacovigilance procedures to be implemented as detailed in the Australian and adopted EU guidelines:
- Risk Management Plans for prescription medicines
- Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines
- EMEA/CHMP/BMWP/42832/2005 Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
The Risk Management Plan is to be submitted with the biosimilar application.
In brief, the mandatory post-registration requirements for pharmacovigilance are that sponsors must:
- notify the TGA of the person responsible for fulfilling the sponsor's obligations
- submit Periodic Safety Update Reports (PSURs) and Adverse Events (AR) reports to the TGA
- notify the TGA when they become aware of any significant safety issues
- ensure that any request from the TGA for the provision of additional information is answered fully and within the requested timeframe.
In addition, any provisions included in the Risk Management Plan that have been imposed as conditions of registration should be fulfilled.
Because all biotechnology-derived products are inherently variable, the established safety record of the reference product does not necessarily apply to the biosimilar. For this reason, it is possible that after assessment of the Risk Management Plan, active pharmacovigilance measures may be applied on a case by case basis.
In submitting adverse event reports, sponsors, patients and health professionals should ensure they clearly identify the product suspected to have caused the adverse event. They should enter:
- the trade name
- the entire non-proprietary name (including any biosimilar identifier) N.B. both the trade name and the non-proprietary name should be given wherever possible
- the AustR number
- the batch number and expiry date
- the dosage form and presentation.