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

  • Eliminating Ferrous Contamination In Critical And Sterile Equipment Maintenance Although the pharmaceutical industry today is a highly automated industry, key decisions are still made by individuals. What equipment you procure, which employees you hire, and how well you train them are all important factors that will have a significant effect on achieving efficient production. In critical and sterile processing, even seemingly small decisions can affect productivity and compliance with regulatory standards. Submitted by Steritool
  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • A Growing Number Of Pharmas Are Thinking Outside The Box
    A Growing Number Of Pharmas Are Thinking Outside The Box

    Everyone knows the mantra – reduce, reuse, recycle – but reusing temperature-sensitive packaging has not been the normal practice in the pharmaceutical/life science sectors. However, changes are afoot.

  • It’s Time To Go Electronic In The Lab – Infographic
    It’s Time To Go Electronic In The Lab – Infographic

    The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.

  • ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?
    ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?

    In the engineering and manufacturing process, we think of a system failure backup as ‘redundant’.   However, in many cases, the development, installation and use of redundant systems can backfire and produce less, not more, reliability.

  • 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.

  • Considerations To Ensure Successful Scale-up Of Single-use Processes
    Considerations To Ensure Successful Scale-up Of Single-use Processes

    Considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.

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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