EDITOR'S DESK

How “Consumer Reports” FDA Approvals Could Hurt Biosimilars

A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars. 

Amgen, Sandoz Biosimilar FDA AdComs: 5 Takeaways

Though both FDA advisory committees unanimously recommended approval and extrapolation of both Amgen's and Sandoz's biosimilars, this process was not as cut-and-dried as expected following the overwhelmingly positive FDA briefing documents. The stumbling points of each committee are important to note prior to your own candidates' FDA submission. 

Post-Brexit: The U.K. Biosimilar Market

In recent weeks, the U.K. made the seismic decision to leave the E.U. But biosimilars aren’t without support. Prior to Brexit, the U.K. celebrated the launch of the BBA, which has several initiatives underway to keep biosimilars a priority in the newly independent country.

Will Teva’s Play Usher Generic, Biosimilar Makers Into “Innovator” Territory?

PhRMA is facing a controversial, potentially industry-altering decision. The generics king Teva has requested to become a member of the trade organization that traditionally represents “innovators”. Could this move redefine the industry's perception of "innovation"?

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GUEST CONTRIBUTORS

  • How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

    This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

  • The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

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BIOPROCESSING WHITE PAPERS

  • Virus Retentive Filtration In Biopharmaceutical Manufacturing

    Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells. Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion.

  • How Broadening The Analysis Of Compound Factors Allows For Predictive Solubility Solutions

    The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.

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INDUSTRY INSIGHTS

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

    Immunoglobulins (Ig), or antibodies (Ab), are the heavy globular plasma proteins produced in response to foreign bodies or antigens. They exist in five isoforms: IgA, IgD, IgE, IgG, and IgM. IgG provides the majority of antibody-based immunity. By Payal Khandelwal, PhD

  • Selecting The Optimal Resins For Mammalian Virus Process Purification And Clearance
    Selecting The Optimal Resins For Mammalian Virus Process Purification And Clearance

    The success of biologics for use in humans depends on the ability to effectively remove any viral contaminants. Viral Clearance from biologics is critical to their performance since they can directly infect mammalian cells and cause diseases such as AIDS, mumps, measles, herpes, hepatitis, meningitis, and shingles. And, conversely, studying these disease causing viruses can aid in the development of preventive and curative therapeutics. In this article, Bio-Rad provides snapshots of the different apatite-based media that can be effectively utilized for the process-scale purification of small to mid-sized viruses.

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

    The development of monoclonal antibody (mAb) technology over the past 25 years has fundamentally changed the questions we ask and led to many innovative discoveries. These highly specific biological products have significantly influenced the direction and progress of research and therapeutics.

  • Canadian Health Product Labeling – The Product Facts Table
    Canadian Health Product Labeling – The Product Facts Table

    Label content pertaining to non-prescription healthcare products is of great concern to the government of Canada. Not only what appears on the label but also the wording, how it appears and how easy it is to understand are all of vital concern.

  • 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.

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LIFE SCIENCE INDUSTRY EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Moist Heat Sterilization Week July 28 - 29, 2016
Bethesda, MD
Moist Heat Sterilization Week July 28 - 29, 2016
Bethesda, MD
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TRAINING COURSES

Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Cleaning Validation – Lessons Learned in the Trenches August 23, 2016
1pm-2:30pm EDT, Online Training
Cloud Computing In A GxP Environment: Three Key Success Factors August 24, 2016
1pm-2:30pm EDT, Online Training
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