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States beg to differ on biosimilar concerns
May 2013
by Lori Lesko  |  Email the author


ANNAPOLIS, Md.—Known as the Old Line State, Maryland has become the fourth state to reject legislation that aims to restrict pharmacists' ability to substitute cheaper biosimilars for their reference biological drugs. The legislators' final vote on April 8 fell in line with the Generic Pharmaceutical Association's (GPhA) stated opinion that such a law "would create red tape between patients and affordable medicines."  
The failed Maryland legislation also would have required pharmacists to give specified notices and record specific information if a pharmacist substituted an interchangeable biosimilar biological product for a prescribed biological reference product.  
"We applaud the Maryland state legislature for making this wise decision," said Ralph G. Neas, GPhA's president and CEO, in an April 10 statement. "Maryland legislators know that passing laws requiring unnecessary notification and recordkeeping 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."  
At issue in the defeated Maryland bill, and in other states as well, is whether to include requirements for physicians and pharmacists on biological substitution. The Patient Protection and Affordable Care Act of 2010, the healthcare reform package signed into law by President Barack Obama, authorized a regulatory pathway for biosimilars. In February 2012, the U.S. Food and Drug Administration (FDA) issued three draft guidances relating to biosimilars. The FDA is expected to release its final guidelines soon.  
The approval pathway, as established by federal law, distinguishes between biologic products that are "biosimilar" to an innovator biologic, meaning they are "highly similar" to an innovator product, and biologic products that meet a heightened standard to be deemed "interchangeable."
While generic drugmakers, pharmacists and pharmacy benefit managers defend and support automatic substitution of biosimilars legislation, it is the FDA which appears to hold all the cards in the center of one of the most controversial legislative issues in years. That's because several states are taking a wait-and-see attitude before bringing biosimilar legislation to a floor vote.
Although the FDA's role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product is prescribed is governed by state law—and getting the states' legislators to agree with the legislation is the crux of the matter for drug companies in light of the 2016 so-called "patent cliff" for many branded biologic therapies.  
While appearing neutral, FDA Commissioner Margaret Hamburg may have tipped her hand. She recently stated that attempts to undermine trust in biosimilars appear to be  "worrisome and represent a disservice to patients who could benefit from these lower cost treatments."  
Three other states—Arizona, Mississippi and Washington—have also rejected similar legislation, while Arkansas concluded that the biosimilar issue warranted further research and sent its legislation back to a committee for further study.  
Although Maryland did not move forward legislation that would have included such provisions, other states have passed such legislation or are considering it. In late March, North Dakota signed into law requirements related to the interchangeability of biological medicines, while Virginia and Utah passed such legislation—but attached were sunset provisions for when the measures would expire.  
Nine other states are considering legislation: California, Colorado, Illinois, Indiana, Florida, Massachusetts, Oregon, Pennsylvania and Texas, according to GPhA.  
In January, the Biotechnology Industry Organization (BIO) issued its "five principles on biologic substitution," a framework of recommendations for states to follow in adopting policy on biological substitution. The BIO principles call for substitution only when the FDA has designated a biologic product as interchangeable, authorizes prescribing physicians to prevent substitution, requires both the prescribing physician and patient to be notified of substitution and requires the pharmacist and the physician to keep records of the substitution.
Code: E051326



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