Interchangeability in Drugs by ANVISA

One of the key sessions of each Biosimilars LatAm event is always dedicated to #regulatory updates led by a Health Regulation Expert or any other Regulatory Authority who can provide the best insights.

?Elkiane Macedo Rama who is a Health Regulation Expert at Brazilian Health Regulatory Agency - ANVISA shared valuable information about the topic - The Medicine Interchangeability during the past forum of Biosimilars LatAm.

When submitting the data required for licensing the approach is quite different if we are talking about a biosimilar, because the focus is on the comparability exercise. In contrast, in a reference product, we focus on #clinicaltrials.

Regarding the comparability exercise, we have multiple guidelines to follow such as the Q5E from ICH, the WHO, EMA, and FDA as well as our guidelines. When assessing the comparability exercises previous knowledge and a good strategy design for the comparability exercise are key to the success of the marketing authorization.

ANVISA launched two resolutions for post-approval changes and stability. The RDC 413/2020 Establishes requirements and procedures for post-approval changes of #biological Products and Resolution RDC 412/2020 establishes requirements and procedures for stability studies of Biological Products. The intention of reviewing these requirements was to harmonize them with internationally accepted ones for other international authorities.

Regarding post-approval changes for #biosimilars, there are no special requirements as a new demonstration of biosimilarity wouldn’t be expected, we use the same rationale as the #innovator product.

"Interchangeability is more directly related to the clinical practice than the regulatory status, which is why we establish based on the comparability exercise if the product is biosimilar but not its interchangeability."

Interchangeability

ANVISA will be also present at the upcoming forum - Biosimilars LatAm - Mexico 2022 organized by JackLeckerman which will launch on November 10th. The last tickets are still available.