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Senate of Pennsylvania
Session of 2015 - 2016 Regular Session


Posted: January 15, 2015 11:45 AM
From: Senator Patricia H. Vance
To: All Senate members
Subject: Memo #4 - Biosimilar substitutions under the Generic Equivenlent Drug Law

In the near future, I will be reintroducing legislation to amend the Generic Equivalent Drug Law regarding biosimilar products. This was SB405 of last session.

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 (FDA) that the prescribed product and the biosimilar product are interchangeable.

A FDA advisory panel unanimously recommended the approval of the first biosimilar application on January 7th. The application will receive final consideration in early March. Two other applications should receive consideration by mid-summer.

Introduced as SB514