FROM THE EDITOR

How Can You Mitigate The Risks Of Single-Use Bags?

The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.

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  • FDA Releases Long Awaited Guidance On Biosimilars Naming
    FDA Releases Long Awaited Guidance On Biosimilars Naming

    After months of debate between reference product makers and generic manufacturers, the FDA released its long-awaited guidance proposing a naming strategy for biosimilars.

  • Could AbbVie Hurt Itself With Biosimilar Labeling Demands?
    Could AbbVie Hurt Itself With Biosimilar Labeling Demands?

    In May, the FDA changed its stance on several key points of its draft version of the “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” In accordance with these changes, any biosimilar licensed under the PHS Act § 351 (k) no longer needs to contain a statement on its label indicating that it is a biosimilar.

  • Do Biosimilars Fit Into The Innovation Paradigm?
    Do Biosimilars Fit Into The Innovation Paradigm?

    As an industry, pharma is inundated with the term “innovation.” Patent laws and data exclusivity negotiations like the stalled Trans-Pacific Partnership (TPP) are centered around protecting innovation. Bayer recently established a team dedicated solely to pursuing innovation — though board member Kemal Malik was quick to tell Life Science Leader magazine that most people in the industry “have a tough time explaining [innovation].”

  • 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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