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

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • The LAL Test: Precautions To Take When Conducting Research Into Pharmaceuticals
    The LAL Test: Precautions To Take When Conducting Research Into Pharmaceuticals

    For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL (Limulus Amebocyte Lysate) test. Using the LAL test, the presence of bacterial endotoxins, lipopolysaccharide molecules (LPS) that are part of the cell wall of Gram-negative bacteria, which are the most common and also the most dangerous pyrogens present in the products of the pharmaceutical industry, is determined.

  • As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry
    As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry

    Over the last few days at ASCO, multiple studies have shown the remarkable potential of matching cancer therapeutics to specific gene mutations, demonstrating that we are truly entering an age of personalized medicine in oncology. Despite all of the promise, the conference discussions also covered many questions yet to be resolved – by academic centers and pharmaceutical companies, doctors, patients and those of us working in the lab.

  • Is your Complex Formulation Process Set Up for Success?
    Is your Complex Formulation Process Set Up for Success?

    This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes.

  • Top Considerations For Selecting The Right Packaging
    Top Considerations For Selecting The Right Packaging

    Determining a product’s temperature range is the first crucial step in packaging evaluation. While vacuum insulated panels (VIPs) with phase change materials (PCMs) remain the gold standard of temperature-controlled transport, many high-value products in today’s market have components that require storage at extreme temperatures — as low as -196°C.

  • Implications Of Inaccurate Forecasting On Biologic Drug Substance Manufacturing
    Implications Of Inaccurate Forecasting On Biologic Drug Substance Manufacturing

    To better understand the issues that biopharmaceutical companies face when planning for clinical and commercial biologic drug substance manufacturing and supply needs, ORC International conducted interviews with biopharmaceutical executives in North America and Europe who consistently utilize forecasts for drug substance and commercial manufacturing planning for biologics. This research explored the causes, consequences, and potential solutions to forecasting challenges specifically related to biologic drug substance manufacturing.

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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