EDITOR'S DESK

  • FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews
    FDA Emphasizes Regulatory Flexibility In Biosimilar Reviews

    A study recently published in the BJCP go a long way toward providing a clear example of what regulatory flexibility looks like in the EMA. But where does the FDA, which got a late start with biosimilars, stand in terms of regulatory flexibility today?

How To Prepare Your Biosimilar Company For Interchangeability

While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward perspective.

3 Lessons From The GPhA Biosimilars Council Conference

This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.

Biobetters: How Much Competition Should Biosimilar Makers Expect?

In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?

The Norwegian Biosimilar Phenomenon: From Biosimilar To “Biogeneric”

Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.

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GUEST CONTRIBUTORS

  • 10 Critical Components Of A Successful Global Drug Development Plan
    10 Critical Components Of A Successful Global Drug Development Plan

    We use plans every day to help us arrive at our desired destinations.  Pilots utilize flight plans prior to take off — although they have flown to their destination perhaps hundreds of times before, they nevertheless reviews and follows a flight plan. Likewise, ship’s captains also file plans and chart courses. Road maps provide guidance on how to drive from point A to point B, though today most people rely on electronic global positioning systems (GPS) to assist with navigation.

  • Best Practices For Measuring System Quality For Drug-Device Combination Products
    Best Practices For Measuring System Quality For Drug-Device Combination Products

    Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.

  • Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
    Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market

    With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.

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BIOPROCESSING WHITE PAPERS

  • Managing Laboratory Consumables

    Since All I Really Need to Know I Learned in Kindergarten first appeared in 1988, its simple, profound wisdom has inspired the world. Among its easily digested messages are a few gems that research scientists would do well to employ in their labs every day: Share everything, Play fair, Put things back where you found them, CLEAN UP YOUR OWN MESS, Don't take things that aren't yours.

  • An Explanation Of IPEC Guidelines The required standards for manufacturing active pharmaceutical ingredients (APIs) are laid out in GMP (good manufacturing practice) requirements. All competent API manufacturers are well aware of these guidelines and must adhere to them, but they only apply to the API and not the excipient.
More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • The Impact Of Waste On The Cost Of Quality In The Pharmaceutical Industry
    The Impact Of Waste On The Cost Of Quality In The Pharmaceutical Industry

    Waste has a significant impact on the cost of quality (COQ)—or more exactly, the cost of poor quality—in the pharmaceutical industry. As a consultant with many years of experience in the industry, I’ve observed the negative effects of waste at many companies, and I want to identify activities that can be defined as “wasteful.”

  • How Do You Inspect Packaging Of Bottles, Cans And Cylinders
    How Do You Inspect Packaging Of Bottles, Cans And Cylinders

    Packaging and labelling is driven by a number of factors. First you have the ergonomics of the package, ensuring that the object is packaged properly ensuring protection, convenience and the proper message is communicated.

  • CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic

    The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world.  With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.

  • The Glioblastoma Multiforme Treatment Market: What’s Ahead In Product Development
    The Glioblastoma Multiforme Treatment Market: What’s Ahead In Product Development

    Currently, the GBM treatment market is in excess of $1 billion in annual sales, which is expected to grow by more than 11 percent between 2014 and 2022 due to rising awareness, research and development in drug delivery technologies, and modern diagnostic techniques. So, what does all of this mean for current GBM patients and the cancer treatment industry going forward?


  • Recent Research On The Issue Of Bacterial Endotoxins
    Recent Research On The Issue Of Bacterial Endotoxins

    Bacterial endotoxins are the most common pyrogens found in pharmaceutical products. These substances are found in the outer membrane of Gram-negative bacteria and when cell lysis occurs in bacteria, they are released to the environment where the bacteria are located. In mammals, bacterial endotoxins, which are lipopolysaccharide molecules, cause various conditions that can lead to such serious complications as a septic shock.

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LIFE SCIENCE INDUSTRY EVENTS

BioNetwork West 2016 October 5 - 7, 2016
Laguna Niguel, CA
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Airflow Visualization Techniques and Practices October 11 - 12, 2016
Bethesda, MD
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them October 14, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses