Tag Archives: biosimilars

FDA Week: For Biologics, A Name Isn’t Just A Name (Jim Greenwood op-ed)

Jim Greenwood

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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BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

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Washington Gov. Jay Inslee to Keynote BIO Convention in China

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Next month, BIO will be hosting our 3rd Annual BIO Convention in China, November 11-13. We are very pleased that Washington Governor Jay Inslee will be joining us as our keynote speaker on November 12. “China is a rapidly growing market for America’s innovative biotechnology companies, including those in Washington State. As this market continues to expand, it will be increasingly important to develop collaborative relationships with the Chinese government, companies, and academic institutions. The BIO Convention Read More >

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State Legislation Needed For Substitution of Interchangeable Biologics

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A great deal of the media coverage relating to California’s Senate Bill 598  neglects to mention a key issue in the biosimilars debate. This bill – or legislation similar to it – is essential to allow for the eventual substitution of interchangeable biologic therapies in the state of California. State laws governing prescription drug substitution were written before the advent of biosimilars and do not take the complexity of biologics into account. California, along with Read More >

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California Continues Responsible Support for Interchangeability of Biologic Drugs

State Capitol

Yesterday, California’s State Assembly Committee on Appropriations took another decisive step when they unanimously voted in support of the revised SB 598 by recommending it back to the full Assembly after minor modifications. This is another important step taken by the California State Legislature to ensure patients and physicians who are managing chronic conditions are made fully aware of which biologic drug is ultimately administered by the pharmacist. When battling a serious disease, patients, physicians Read More >

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