The lecturers will discuss the development, regulations, and marketing of various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products. It will be a unique experience to overview this very rapidly developing field and to understand how do these types of drugs modify the marketing policy of medicinal products.
1. Compare the scientific and regulatory basis for the definitions of the various types of follow-on drugs: generic, biosimilar and non-biological similar medicinal products, define their significance in the life-cycle management of medicines.
2. Choose the right timing of pharmacokinetic studies during follow-on drug development.
3. Assess the appropriate in vitro and in vivo methods to establish equivalent bioavailability of generic drugs.
4. Analyze the diversity caused by the development of independent formulations for the same active ingredients by the follow-on producer.
5. Comprehend and appreciate the causes leading to the diversity of the biosimilar medicinal products manufactured by different producers.
6. Appreciate the complex non-clinical and clinical comparative study requirements needed to evaluate the biological and immunogenic properties of biosimilar medicinal products including biosimilar monoclonal antibodies
7. Appreciate the specific properties of different complex non-biological similar medicinal products
8. Analyze, comprehend and assess the complexity and international diversity of regulatory requirements for evaluating the efficacy and safety of follow-on non-biological similar products
9. Evaluate the public health significance of follow-on drugs on the market. Comprehend the differences in the pricing principles of follow-on generic, biosimilar and non-biological medicinal products
10. Assess the clinical pharmacological problems associated with reference pricing
11. Appraise the various clinical pharmacological issues related to the clinical interchangeability of generic, biosimilar and non-biological similar products drugs.
12. Appraise the international significance of quality assurance of follow-on products.
13. Assess the international medical significance of counterfeiting drug.
14. Appreciate the factors influencing the adoption of follow-on drugs in the everyday practice.
Pharmaceutical medicine. Medicines development, regulation and marketing of drugs.