Tag Archives: biosimilars

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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Ensuring the Safety and Commercial Success of Biosimilars in the United States

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The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that the FDA and industry should take to ensure patient safety while promoting market competition and continued biomedical innovation. During a presentation Tuesday at the 2014 BIO International Convention, participants at this Super Session focused on the need for prescribing physicians and providers to closely partners with one another to ensure that safety and efficacy are the priorities in the debate 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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FDA Week: For Biologics, A Name Isn’t Just A Name (Jim Greenwood op-ed)

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What is in a name? Names help make medicinal products more easily distinguishable by doctors, pharmacists and patients. When you are talking about biologics, complex medicines that are manufactured using living organisms, and biosimilars, medicines that are similar to, but not the same as, innovator biologics, naming is a significant consideration. As a pathway for biosimilars approval is implemented, a clear priority should be to craft a naming convention that both contributes to patient safety Read More >

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