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

  • Noncompliance To FDA Quality Standards: What's The Risk To Executives?

    Just imagine. Your company — hypothetically speaking — is now a successful and growthoriented organization. Thus far, you’ve kept governmental regulations in check, quality is steadily improving, and you’ve even managed to lower the cost of production. Then one day, the FDA shows up for an unannounced inspection of your facility. By Michael S. Heyl, J.D. Hogan & Hartson LLP

  • Grant Payment Practices: Five Requirements For Stronger Investigator Relationships

    In the clinical trials industry, profitability and regulatory compliance pressures continue to mount. Consequently, pharmaceutical companies are striving to maximize their research and development spending by reducing clinical trial cycle times and focusing on their core competencies—all while maintaining high standards of quality. By James M. Dicesare and Kevin T.Williams, Clinical Financial Services, LLC (CFS).

     

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INDUSTRY INSIGHTS

  • 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.

  • How Sustainability Efforts Change Your Supply Chain For The Better
    How Sustainability Efforts Change Your Supply Chain For The Better

    Going green is moving from a clichéd corporate phrase to simply the way business is run. Companies around the globe continue to make significant investments in sustainability that benefit not only the environment, but also the customers they serve. What does green mean for specialty logistics — and why does it matter for your supply chain? World Courier explores a few of the most critical questions shippers are asking when it comes to eco-friendly innovation.

  • CMO Selection: Going From "Could Fit" To "Good Fit"
    CMO Selection: Going From "Could Fit" To "Good Fit"

    Where does one start? For most drug owners seeking contract manufacturing support, it all depends on the type of product that they have. There’s always a set of established criteria, but there are a few other things for partner-seeking companies to look at, but it really depends on the mix and the philosophy of the organization, their cost sensitivity, price sensitivity, how aggressive they want to be, etc.

  • Why Russia Is An Attractive Market For Clinical Trials
    Why Russia Is An Attractive Market For Clinical Trials

    The largest country in the world, Russia is bigger than Pluto at 16.6million km2, and is separated from the USA by less than 4 km. Still nominally at war since 1945 with Japan over the Kuril Islands, it has 20% of the world’s unfrozen fresh water in a single lake, Lake Baikal. It spans nine time zones, has 28 official languages and has the world’s longest railway. The first Russian child to receive the vaccine against smallpox was called “Vaccinov,” given a pension, and observed throughout his life.

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

    The number of gene therapy–based treatments has grown significantly since they first appeared nearly three decades ago. This has created profound optimism about our potential to develop a cure for diseases such as cancer and AIDS.

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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