why biotechs need to worry about generics, too, page-2

Q. What can a biotech do to extend the exclusivity of its original biologic drug?

A. If they can make a structural change in [their] biologic, and that change can result in [a] change in safety, potency or purity, you can file a new BLA or a supplemental BLA [Biologics License Application with the FDA] and you may be eligible for a new 12 years of exclusivity. You take that biologic you originally had, you change the structure, [and] you get a new product.

Somebody say safety?