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House Co-Sponsorship Memoranda
House of Representatives
Session of 2015 - 2016
Regular Session
MEMORANDUM
| Posted: | February 2, 2015 10:08 AM |
|---|---|
| From: | Representative Bryan Cutler |
| To: | All House members |
| Subject: | Biosimilar Substitutions Under the Generic Equivalent Drug Law-Previously HB 746 |
| 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 band 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. Last session, this was the companion legislation to Senator Vance's SB 405 which successfully passed the Senate and had been on first consideration in the House. PREVIOUS CO-SPONSORS: GINGRICH, BIZZARRO, COHEN, SWANGER, WATSON, PASHINSKI, MILLARD, PETRI, SAYLOR, C. HARRIS, R. BROWN, GROVE, V. BROWN, STERN, ROSS, LAWRENCE, DeLUCA,K., BOYLE, KORTZ, GRELL, ELLIS, HENNESSEY, DiGIROLAMO, BRIGGS,PEIFER, KAMPF AND MILNE |