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

  • Accelerating Biopharmaceutical Development From DNA To Drug

    The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.

  • 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

  • The Changing Biopharma Risk Equation
    The Changing Biopharma Risk Equation

    As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product—ranging from well-established large molecule drugs to truly novel therapies—poses major challenges because of their scientific complexity and sophisticated development requirements.

  • 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.

  • Selecting The Optimal Resins For Aggregate Removal
    Selecting The Optimal Resins For Aggregate Removal

    The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.

  • 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

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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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