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Senate of Pennsylvania
Session of 2013 - 2014 Regular Session


Posted: December 20, 2012 10:46 AM
From: Senator Patricia H. Vance
To: All Senate members
Subject: Memo #5 - Biosimilar substitutions under the Generic Equivenlent Drug Law
In the near future, I will be introducing legislation to amend the Generic Equivalent Drug Law regarding biosimilar products.

Generic drugs and biosimilar medications have very different chemical make-ups. As a result, the laws currently applicable to generics cannot be applied uniformly to biosimilar products. Generic drugs have identical active substances as their brand counterparts while biosimilars are only comparable and are not always “scientifically appropriate” for substitution.

Current Pennsylvania law permits the automatic substitution of a less expensive generic drug for a brand name drug unless the physician indicates the brand is medically necessary. This legislation will create a new section pertaining to biosimilar products. When dealing with biologics, this substitution may not always be the best course of treatment for a patient. Substitution will only be permitted if certain minimal thresholds are met including a decision by the United States Food and Drug Administration that the prescribed product and the biosimilar product are interchangeable.

Introduced as SB405