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

  • Poor Assay Precision Poor assay precision is almost always due to procedural or equipment issues within your laboratory. The kit reagents are well validated and tested for stability while the coating of antibody on the plates is very uniform. By Cygnus Technologies Inc.
  • White Paper: The Importance Of Training Predictors Prediction accuracy is of prime concern when evaluating a new software predictor. While the quality of the prediction algorithm impacts accuracy, a more important factor is whether the prediction covers the appropriate chemical space for compounds under investigation. By Advanced Chemistry Development, Inc.
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INDUSTRY INSIGHTS

  • How To Boost Profits With Single-Use Powder Transfer In Biopharma
    How To Boost Profits With Single-Use Powder Transfer In Biopharma

    Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

  • Getting The Most Out Of Your Viral Clearance Study
    Getting The Most Out Of Your Viral Clearance Study

    By John Zehmer, PhD, Senior Scientist and Study Director at BioReliance

    Conducting a viral clearance study is an important step on the road toward getting your biomolecule into the clinic and on its way to becoming a drug. However, since most companies do not have the systems in place to support a regulated virological study of this kind, this will likely mean engaging a contract research organization (CRO) as a partner. The keys to meeting your goals are solid planning and good communication between your group and your CRO partner. This article provides a high-level review of these processes and will aid in planning for a successful study.

  • Astounding Results Of Combination Checkpoint Inhibitor Therapy Tempered By Discussions Of Rising Cost Of Cancer Care
    Astounding Results Of Combination Checkpoint Inhibitor Therapy Tempered By Discussions Of Rising Cost Of Cancer Care

    The third day of ASCO highlighted the science and remarkable advances emerging from the new immunotherapies, but excitement was tempered by concerns over cancer costs.

    The plenary session began with a lecture by Dr. James Patrick Allison of M.D. Anderson, and a review of his work in immunotherapy that started in 1995. This work revolutionized cancer treatment, with three new IO drugs on the market and more in development. His talk laid the foundation for Dr. Jedd D. Wolchok of Memorial Sloan Kettering who presented the much-anticipated results from a Phase III randomized trial comparing the efficacy and safety of Bristol Myers Squibb’s nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naïve patients with advanced melanoma.

  • Improve Operations, Collaboration, And Time-To-Market: The Digital Lab
    Improve Operations, Collaboration, And Time-To-Market: The Digital Lab

    Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations.

  • Risk In Pharmaceutical Packaging
    Risk In Pharmaceutical Packaging

    Shifting the industry from a compliance culture to a quality culture in pharmaceutical packaging.

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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