EDITOR'S DESK

  • Biobetters: How Much Competition Should Biosimilar Makers Expect?
    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.

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.

More From Our Editors

GUEST CONTRIBUTORS

  • A Working Introduction To Six Sigma For Pharmaceutical Manufacturers
    A Working Introduction To Six Sigma For Pharmaceutical Manufacturers

    This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.

  • Early Implementation Of Quality By Design For Biological Product Development
    Early Implementation Of Quality By Design For Biological Product Development

    The idea of thinking in terms of “operational excellence” is a relatively new idea for the biopharmaceutical industry. The enormous uncertainty associated with bringing a biological drug product from discovery to approval almost precludes the thought of forward-thinking in terms of what makes a quality product, especially during early-stage development. However, extensive product knowledge is gathered during early development, and crucial decisions are made in terms moving the science forward to generate the data required to meet your business objectives.

  • Anti-TNF Biosimilars In Europe: What Matters Beyond Price?
    Anti-TNF Biosimilars In Europe: What Matters Beyond Price?

    The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.

  • CAR T-Cell Therapy: The Road Ahead

    In recent years, we have witnessed a meteoric rise in clinical studies of cancer immunotherapies, catapulting immuno-oncology into one of the fastest growing and dynamic areas in pharmaceutical development today.

  • Managing QMS Disparities Between Drugs And Devices For Combination Products

    Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences , projected to grow to $115 billion by 2019.

More From Guest Contributors

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.

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • From Outsourcing To Partnership
    From Outsourcing To Partnership

    A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the MilliporeSigma BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.

  • Reducing Analytical Method Steps For Accelerated Product
    Reducing Analytical Method Steps For Accelerated Product

    With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients.

  • BIO 2016 Survey: Where Is Biopharma Headed?
    BIO 2016 Survey: Where Is Biopharma Headed?

    15,937 industry leaders, 40% of which were C-level executives, attended the BIO International Convention in San Francisco that ran June 6-9. The MilliporeSigma team used this opportune gathering of the biopharma industry to unveil the findings of a study that it recently sponsored with The Economist Intelligence Unit, titled The Changing Biopharma Risk Equation.

  • 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 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.

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Analyzing and Understanding ISO 13485 Proposed Changes August 30, 2016
1pm-2:30pm EDT, Online Training
Effective Clinical Investigator GCP Training - Getting It Right The First Time August 30, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Environmental Monitoring Course Series August 30, 2016 - September 1, 2016
Bethesda, MD
Recommended Practices for Manual Aseptic Processes September 7 - 8, 2016
Bethesda, MD
More Industry Events

TRAINING COURSES

Effective Clinical Investigator GCP Training - Getting It Right The First Time August 30, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Analyzing and Understanding ISO 13485 Proposed Changes August 30, 2016
1pm-2:30pm EDT, Online Training
Drug Development 101 – How A Drug Is Made September 13, 2016
1pm-2:30pm EDT, Online Training
Update to ICH GCP E6 (R2) – Proposed Changes You Should Prepare For September 14, 2016
1pm-2:30pm EST, Online Training
More Upcoming Courses