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.

More From Our Editors

GUEST CONTRIBUTORS

  • 5 Steps To Build A Quality Culture That Supports Data Integrity

    When it comes to building a culture of quality, many companies ask, "Where do we start?”

  • How Health Systems Will Manage Biosimilars: Implications For Manufacturers

    The FDA recently approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), for multiple indications, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. Despite being studied in clinical trials only for rheumatoid arthritis and ankylosing spondylitis, the FDA granted infliximab-dyyb nearly all of Remicade’s indications based on the infliximab-dyyb clinical package. The FDA stopped short of determining the biosimilar to be “interchangeable,” as standards for interchangeability have not yet been finalized.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • 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.

  • 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.

  • Good Manufacturing Practice: The DNA of Pharmaceutical Quality
    Good Manufacturing Practice: The DNA of Pharmaceutical Quality

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. 

  • How To Avoid 5 LIMS Nightmares
    How To Avoid 5 LIMS Nightmares

    Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

  • Missed Opportunities For Adventitious Agents Testing
    Missed Opportunities For Adventitious Agents Testing

    Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.

More Industry Insights

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