FROM THE EDITOR

Shaping The Emerging Biosimilars Landscape

The emergence of biosimilars in the U.S. will  undoubtedly have a marked impact on the pharmaceutical industry, but the market is young and malleable. Pharmaceutical manufacturers currently have a unique opportunity to shape perceptions and use of biosimilars among healthcare providers and their patients.

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PHARMA CONTRIBUTING EDITORS

  • Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?
    Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?

    Last week, Matthew Harper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

  • Making The Switch To Single-Use: Have You Thought Of Everything?
    Making The Switch To Single-Use: Have You Thought Of Everything?

    In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.

  • Is Sustainability Possible With Single-Use Technology?
    Is Sustainability Possible With Single-Use Technology?

    At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?

  • Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”
    Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”

    The past few weeks, the generics market has seen several players jump ship and one company grow significantly — and to some, alarmingly — larger.

  • TPP Negotiations Stall, Hold Back Biosimilars Market
    TPP Negotiations Stall, Hold Back Biosimilars Market

    As if the biosimilar naming debate between brand-name pharmaceutical companies and generic drugmakers wasn’t enough, these two sides continue to challenge each other — this time, over biologics data exclusivity in the ongoing Trans-Pacific Partnership (TPP) negotiations.

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