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

  • Overcoming The Barriers To Global Biosimilar Adoption
    Overcoming The Barriers To Global Biosimilar Adoption

    This article will be part of the CPhI 2016 Annual Report, which will be released during the CPhI Worldwide event in Barcelona (October 4-6, 2016).

  • 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.

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BIOPROCESSING WHITE PAPERS

  • Avoiding The Gas-Guzzler: 8 Steps To More Productive Observational Studies

    When it comes to the subject of research studies, and specifically to observational, non-interventional studies. Suffice it to say that our industry needs to retool in order to cost-effectively respond to the need for these unique types of studies. By Jeff Trotter, Executive Vice President, Phase IV Development

  • Steps To Improve Collection, Management And Analysis Of Microbiology Samples

    Those who work in microbiology laboratories are aware of just how complex and expensive in terms of time and human resources, the collection, management, reading and interpretation of the data generated by the numerous samplings to keep up with the regulations for the release of pharmaceuticals. Their efforts for some time now do not seem to be enough. Inspectors devote more attention to the activities of the microbiology laboratory and, increasingly, their requirements are reports, statistics, correlations between the data, with the paper-based system, there may be only partially fulfill or at least not within the time limited and urgent inspections.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Streamlining Recombinant Protein Production
    Streamlining Recombinant Protein Production

    Use of recombinant proteins as therapeutics has become an attractive strategy for altering the biology of disease progression and offers significant commercial opportunities.  However, bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.

  • One Region, A Thousand Challenges
    One Region, A Thousand Challenges

    As the recent Economist Intelligence Unit survey showed, Asia remains an important region for biopharma, with some notable trends appearing for the next five years. We spoke about these findings with MilliporeSigma’s Julien Zhao (Biosimilar and Emerging Biotech Markets Manager, Asia) and MS Mahadevan (Head of Actives and Formulations, Asia Pacific) to hear their take on Asian market evolution, crossborder collaboration, and why countries like Indonesia might just be the future of the industry.

  • 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
    3 Steps To Prepare For FDA’s Final Quality Metrics Guidance

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  • Selecting The Optimal Resins For mAb Process Purification
    Selecting The Optimal Resins For mAb Process Purification

    The development of monoclonal antibody (mAb) technology over the past 25 years has fundamentally changed the questions we ask and led to many innovative discoveries. These highly specific biological products have significantly influenced the direction and progress of research and therapeutics.

  • 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.

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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