2019 Round Table

Regulation of Biodrugs: interchangeability, substitution & switch

2019 regulation of biodrugs

Importance of control and management of the complexity of Biosimilars. It is the tole of the authorities to study the concept of interchangeability and decide on these following comparability studies

- Comparability is demonstrated with quality and bioequivalence studies
- Question of the comparator element during comparability tests
- What are the best studies for demonstrate comparability?

The decision-maker (authorities) must position himself on the question of interchangeability and the payer on the question of switch / substitution
- Importance of also implementing the tools to implement the strategy in the market, that the strategy be applicable

Audience

Attending Experts

Dr. Yagoub Ghania

Ministry of Health, Population & Hospital Reform Algeria

Dr. Achouak Ghorab

National Agency of Pharamceutical Products

Dr. Michael Muenzberg

Dr. Valderilio Azevedo

EDUMED

Dr. S. Harinarayana Rao

Reliance Life Sciences

Pr. Ahlam Abdelaziz

JFDA

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