Table : Sponsor’s bridging strategy Symbicort Rapihaler Evidence supporting therapeutic equivalence with Symbicort Turbuhaler Clinical studies / in TGA approval status data 50/3 Clinical Clinical evaluator (D5897C00003) recommended approval demonstrating in vivo on demonstration therapeutic equivalence of therapeutic with Symbicort equivalence [and Turbuhaler 100/6 subsequently registered] 100/3 Combination of Approval sought via therapeutic equivalence proven in vivo demonstrated for 50/3, therapeutic 100/6, and 200/6 and in equivalence in clinical vitro data across all 4 studies for Rapihaler strengths formulation strengths that bracket Symbicort Rapihaler 100/3 ( 50/3, 100/6, and 200/6) and in vitro data showing linear dose relationships for both active ingredients from all formulation strengths 100/6 Clinical Approved by TGA; based demonstrating in on demonstration of vivo therapeutic therapeutic equivalence equivalence with Symbicort Turbuhaler 100/6 200/6 Clinical study Approved by TGA; based demonstrating in on demonstration of vivo therapeutic therapeutic equivalence equivalence with Symbicort Turbuhaler 200/6 In terms of the formulation, the only difference between the new Symbicort Rapihaler 50/3 and 100/3 strengths and the approved higher strength Rapihaler products is the concentration of the drug substances. The composition of excipients is identical for all the strengths. All the Rapihaler products use the same valve metering chamber volume. The Symbicort Rapihaler 100/3 formulation strength has been developed to deliver, ex actuator, twice the dose of budesonide and an equivalent dose of formoterol as is delivered by the Symbicort Rapihaler 50/3 (that is, the same relationship as for Symbicort
Table : Sponsor’s bridging strategy Symbicort Rapihaler Evidence supporting therapeutic equivalence with Symbicort Turbuhaler Clinical studies / in data TGA approval status 50/3 Clinical (D5897C00003) demonstrating in vivo therapeutic equivalence with Symbicort Turbuhaler 100/6 Clinical evaluator recommended approval on demonstration of therapeutic equivalence [and subsequently registered] 100/3 Combination of proven in vivo therapeutic equivalence in clinical studies for formulation strengths that bracket Symbicort Rapihaler 100/3 ( 50/3, 100/6, and 200/6) and in vitro data showing linear dose relationships for both active ingredients from all formulation strengths Approval sought via therapeutic equivalence demonstrated for 50/3, 100/6, and 200/6 and in vitro data across all 4 Rapihaler strengths 100/6 Clinical demonstrating in vivo therapeutic equivalence with Symbicort Turbuhaler 100/6 Approved by TGA; based on demonstration of therapeutic equivalence 200/6 Clinical study demonstrating in vivo therapeutic equivalence with Symbicort Turbuhaler 200/6 Approved by TGA; based on demonstration of therapeutic equivalence In terms of the formulation, the only difference between the new Symbicort Rapihaler 50/3 and 100/3 strengths and the approved higher strength Rapihaler products is the concentration of the drug substances. The composition of excipients is identical for all the strengths. All the Rapihaler products use the same valve metering chamber volume. The Symbicort Rapihaler 100/3 formulation strength has been developed to deliver, ex actuator, twice the dose of budesonide and an equivalent dose of formoterol as is delivered by the Symbicort Rapihaler 50/3 (that is, the same relationship as for Symbicort
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