creation of 3 new groups
Par decision of June 6, 2024 [1]the National Agency for the Safety of Medicines and Health Products (ANSM) has created within the generic directory [2] three new groups:
- Group APREMILAST 30 mg film-coated tablet :
- referent: OTEZLA 30 mg film-coated tablet;
- OTEZLA is indicated for the treatment of psoriatic arthritis, psoriasis and Behçet’s disease. This specialty in a box of 56 tablets dosed at 30 mg of apremilast is used in the treatment ofinterview, at a dosage of 1 tablet morning and evening; as a reminder, a group was created in May for the specialty ofinitiation OTEZLA 10 mg/20 mg/30 mg film-coated tablet (see. our article of May 30, 2024)
- the generic specialty VOYFLEN included in this group is not marketed as of June 18, 2024.
- Two groups DEGARELIX (ACETATE DE) equivalent to DEGARELIX 80 mg and DEGARELIX 120 mg powder and solvent for solution for injection :
- respective referents: FIRMAGON 80 mg and FIRMAGON 120 mg powder and solvent for solution for injection;
- FIRMAGON is an antagonist of the gonadotropin-releasing hormone (GnRH). It is indicated in the treatment of different forms of hormone-dependent prostate cancer in adults;
- the generic specialties DEGARELIX ACCORD 80 mg and 120 mg listed in these groups are not marketed as of June 6, 2024.
The inclusion of specialties in the generic directory does not prejudge their effective marketing. This depends in particular on the expiration date of the intellectual property rights of the original specialty.
The inclusion of a specialty in the generic directory is a essential condition for substitution during delivery to the pharmacy. The differences in excipient composition between originators and generics are specified in the generics directory.
