2.17 Biotech drugs are those produced within living biological systems. Making these drugs is quite complicated and can be very sensitive to small manufacturing changes. The Food and Drug Administration (FDA), which must approve any drug before it is marketed, is trying to determine the procedures it will require to allow the production and sale of generic copies of biotech drugs that can be labeled as interchangeable with the original brands (called biosimilar interchangeability).

a. As a manager of a biotech company that manufactures an approved biotech drug with an expired patent, what arguments would you make to the FDA regarding approval of interchangeable biosimilar drugs?

b. If you are a manager of a generic drug company, what arguments would you make to the FDA?