GPhA Congratulates Maryland Legislature on its Decision to Forgo Premature State Legislation on Interchangeable Biosimilars

Published Online: Wednesday, April 10, 2013
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WASHINGTON, DC — Late on Monday, legislation to create barriers between consumers and promising biosimilar medicines failed to move forward in the Maryland state legislature, ending discussion on the bill for this year. Biosimilar medicines are newer, more affordable versions of biologic medicines that have been on the market in Europe for seven years, but are not yet available on the U.S. market.

“We applaud the Maryland state legislature for making this wise decision,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. “After hours of testimony, Members of the House were convinced that now is not the time to take action. Maryland spent nearly $24.7 million on costly biologic medicines in their state Medicaid program in 2011 alone. With this much at stake, Maryland legislators know that passing laws requiring unnecessary notification and record keeping would create ‘red tape’ between patients and affordable medicines. We agree with the Maryland Department of Health and Mental Hygiene, which in opposing this legislation called it ‘premature and unnecessary at this time’.”

Arizona, Mississippi, and Washington State have also recognized that acting before the FDA has issued final guidance on biosimilars is premature, and have declined to pass similar legislation. Arkansas concluded that this issue warranted further research, and sent their legislation to a study committee.

North Dakota is the only state that has passed this type of legislation intact. While Virginia and Utah passed similar laws, the bills were hobbled by a sunset clause, which most experts believe will render the laws moot before biosimilars come to market.

Similar bills are currently under consideration in 9 additional states: California, Colorado, Illinois, Indiana, Florida, Massachusetts, Oregon, Pennsylvania and Texas.

References:

“Battle in States on Generic Copies of Biotech Drugs” – The New York Times

GPhA Statement on The New York Times article

The New York Times: Improper Efforts to Limit Competitive Drugs

LA Times: Battle over biosimilars

ACS CAN’s Statement on State Biosimilar Legislation

Nature Biotechnology: Building a Wall against Biosimilars

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