Tag Archives: biologic

Docs to FDA: Biosimilars should have different names than branded drugs

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Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars “must have distinguishable nonproprietary names. The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names. The physicians argued that using different Read More >

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BIO Recognizes the Work of Two Indiana Legislators

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Across the country state lawmakers are addressing the issue of biosimilars, lower-cost biologic medicines that stand to benefit severely ill patients combating complex and life threatening diseases. Indiana has been at the forefront of this important issue, and two Indiana state legislators, Representative Ed Clere and Senator Brandt Hershman, were particularly instrumental to the success of biosimilar legislation that was recently signed into law by Governor Mike Pence. Representative Ed Clere (District 72), is Chair Read More >

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Indiana Governor Signs Bill that Supports Transparent Communication

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Indiana Governor Mike Pence has signed bipartisan legislation enabling retail pharmacies within his state to substitute interchangeable biologic medicines, once approved, for the innovator drug on which they are based. Not only does this legislation empower pharmacists to use their professional discretion to automatically substitute interchangeable biologic medicines, it also ensures transparent communication within a patient’s entire health care team to ensure the best decisions possible. The newly signed Senate Bill 262 ensures pharmacists communicate with the Read More >

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