Regulatory Decision Summary for Hadlima / Hadlima PushTouch

In this Supplement to a New Drug Submission (SNDS), no changes to the currently authorized indication or posology were sought, only the authorization of the new 100 mg/mL formulation of adalimumab.

The authorization was based on Study SB5-1003 which compared the relative bioavailability of the two drug product strengths of adalimumab (50 mg/mL and 100 mg/mL) in healthy male subjects using the pre-filled syringe presentation. The adalimumab 50 mg/mL and 100 mg/mL formulations were shown to meet the pre-specified criteria for bioequivalence when administered subcutaneously as a single dose of 40 mg. There was no meaningful differences in exposure between the authorized adalimumab 50 mg/mL strength and the new 100 mg/mL strength. The new 100 mg/mL formulation requires only half the injection volume of the 50 mg/mL formulation to achieve the same prescribed dose of 40 mg. Based on the comparative bioavailability data, no differences in terms of efficacy is expected based on the formulation.

The safety profile of the adalimumab 100 mg/mL formulation was consistent with the safety profile of the 50 mg/mL formulation in healthy male subjects. No new or unexpected safety findings were identified.

The benefit/risk profile of adalimumab remains favourable for all the indications for which this product is authorized.