8  FDA Approval and Post-Market Surveillance

This lecture focuses on the following contents:

1. Post-market surveillance (i.e., phase IV)
2. Pricing
3. Life cycle of drugs and biosimilars

Major Drug Regulatory Agencies in Nations

The above figure lists some major drug regulatory agencies in various nations (including Singapore). Also recall that it takes about 12 years for a drug to go from its discovery to market authorization.

8.1 Objectives of Postmarketing Surveillance Trials

Objectives of Phase IV Trials

The above figure lists some objectives in of postmarket surveillance.

8.1.1 Sales

Sales in the Monoclonal Antibody Market

Prices for monoclonal antibodies are also influenced by numerous factors:

Factors that Influence Price Sensitivity in the mAB Market

Pricing Rates for Monoclonal Antibodies in the USA

The above figure shows average pricing rates for monoclonal antibodies depending on the kind of treatment that the mAB in question is used for.

Factors that Influence Purchasing

There are also several layers that influence the sale of a monoclonal antibody.

8.2 Lifecycle of Drugs

Lifecycle of a Drug in Profits

Comparisons of Costs and Focuses Between Biologics and Biosimilars