Are there any minor updates to pivotal studies or N/A supportive studies available that were not Yes provide details as annotations within PI considered in the COR approval supporting the with references to relevant documentation. proposed indication. Is there any additional information available No eligible for COR-A or COR-B relevant to the risk-benefit of the indication Yes eligible for COR-B only approved overseas (e.g. additional Periodic Safety Update Report (PSUR) or long term safety study available since COR approval)? No new studies, major variations or substantial Yes eligible for COR-A or COR-B updates have occurred since the goods were No this application is not eligible for the COR evaluated. report-based process. (PI) Include as annotated commentary in the PI Completed document: A justification for the proposed Australian Pregnancy Category. Details of the species, sex, route, upper doses and relative exposure achieved in cited animal studies for Fertility, Use in Pregnancy and Carcinogenicity (where not included in the COR report). Any differences between the proposed Australian indications, dosing and administration details and those approved in the COR report. Any new studies or data updates from what was assessed by the COR. Risk Management Plan (RMP) Refer to RMP requirements within and the . RMP: NCE/NBE or EOI and Biosimilar Applications Is an RMP/Australian Specific Annex (ASA) Yes continue to Q2 required? No no further RMP questions. Have you submitted an ASA or an Australian ASA continue to Q3 RMP in Module 1.8.2? Aus-RMP continue to Q7 No application is not effective.
Are there any minor updates to pivotal studies or supportive studies available that were not considered in the COR approval supporting the proposed indication. N/A Yes provide details as annotations within PI with references to relevant documentation. Is there any additional information available relevant to the risk-benefit of the indication approved overseas (e.g. additional Periodic Safety Update Report (PSUR) or long term safety study available since COR approval)? No eligible for COR-A or COR-B Yes eligible for COR-B only No new studies, major variations or substantial updates have occurred since the goods were evaluated. Yes eligible for COR-A or COR-B No this application is not eligible for the COR report-based process. (PI) Include as annotated commentary in the PI document: A justification for the proposed Australian Pregnancy Category. Details of the species, sex, route, upper doses and relative exposure achieved in cited animal studies for Fertility, Use in Pregnancy and Carcinogenicity (where not included in the COR report). Any differences between the proposed Australian indications, dosing and administration details and those approved in the COR report. Any new studies or data updates from what was assessed by the COR. Completed Risk Management Plan (RMP) Refer to RMP requirements within and the . RMP: NCE/NBE or EOI and Biosimilar Applications Is an RMP/Australian Specific Annex (ASA) required? Yes continue to Q2 No no further RMP questions. Have you submitted an ASA or an Australian RMP in Module 1.8.2? ASA continue to Q3 Aus-RMP continue to Q7 No application is not effective.
application-checklist-for-cor-report-based-process.docx