Section 3a: Similar biological medicinal products

The reference list of similar biological groups provided for in article L. 5121-10-2 is presented for each reference biological medicinal product for which the name, strength, pharmaceutical form and common name of the active substance it contains are indicated. This list includes the medicinal products included in each similar biological group within the meaning of b of 15° of article L. 5121-1 and specifies, for each of these medicinal products,…

When a marketing authorisation is granted for a biological medicinal product which may be identified as a similar biological medicinal product, the Director General of the Agence nationale de sécurité des médicaments et des produits de santé : 1° Identifies it as a similar biological medicinal product, mentioning the corresponding reference medicinal product, by means of a decision, which may include recommendations and warnings, and which he notifies to the…

The Director General of the Agence nationale de sécurité des médicaments et des produits de santé: 1° Suspends or withdraws the decision referred to in 1° of Article R. 5121-9-2 identifying a similar biological medicinal product in the event of non-renewal, suspension, withdrawal or lapse of the marketing authorisation for this medicinal product; 2° Removes the similar biological medicinal product from the reference list of similar biological groups in the…

Decisions to include a medicinal product on the reference list of similar biological groups, to amend these decisions and to remove it from this list are published on the website of the Agence nationale de sécurité du médicament et des produits de santé.