Evergreening, Other Fears Emerge as FDA Works to Define Biosimilars Pathway

While the legislative intent in the biosimilars provision of the healthcare reform bill was to create an expedited pathway for the approval of generic biologics, the actual language is fairly ambiguous, legal experts say. One major question is how the law’s exclusivity provision will be interpreted by the FDA and whether that interpretation could lead to so-called evergreening of brand biologics — where even a small change in the manufacturing process for an already-marketed biologic could offer another 12 years of exclusivity to its owner.
Drug Industry Daily