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Generics are Coming For Biologic Drugs

Biologic Drugs

They are calling the Generic for Biologic Drugs, Subsequent-Entry Biologics (SEB). The Subsequent-Entry Biologics are 15% and in some cases a 47% reduction in cost.  Green Shield, an Insurance Company that specializes in Extended Health and Dental Benefits, has created policies surrounding this.

So then, what’s an Subsequent-Entry Biologic?

An Subsequent-Entry Biologic is a biologic product that is similar to an approved originator (or innovator) biologic product. Like all biologics, Subsequent-Entry Biologics are complicated to develop and manufacture, and even small differences in production can make a difference in the way they work. Therefore, while they are similar to traditional generic drugs in that they are produced after the patent of the original biologic drug expires, they can’t technically be thought of as “generic biologics.” Unlike true generics, which are considered “bioequivalent” and therefore interchangeable with the brand-name drug,Subsequent-Entry Biologic  are not automatically interchangeable, and any new Subsequent-Entry Biologic that comes along is treated like a new drug.

Green Shield’s Policy

After considering this evidence as well the implications, and alternatives for covering SEBs, GSC has developed a unique approach: we are the first benefits provider to list SEBs as preferred products under our formularies. This means the originator products will be covered only in exceptional circumstances. Currently, this policy will apply to new starts; patients on the originator products will be grandfathered.

Green Shield tends to be the leader in policies surrounding changes in the prescription drug world.  Will the rest of the Insurance Companies follow their lead?

If you are concerned on how this may affect your employees, please contact me for further information.

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