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

  • 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.

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BIOPROCESSING WHITE PAPERS

  • The Case For Integrated Processes Whitepaper: The Case For Integrated Processes
  • Research Efficiency In Hard Times: It’s Time To Adapt

    Nobody likes hard times, but they do have one redeeming quality: They focus attention on areas neglected in good times. The need for greater efficiency is a prime example, especially for small drug development companies. Even in the best of times, they must cope with the formidable combination of high costs, long timelines, and low success rates. And when hard times come, they feel it first and most acutely. These companies should be the first to ask: Is there a better way? By Michael Rosenberg, M.D., MPH, Life Science Leader magazine

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INDUSTRY INSIGHTS

  • Pharma Seeks Long Tail Of Flexible Manufacturing
    Pharma Seeks Long Tail Of Flexible Manufacturing

    The pharmaceutical industry is at the cutting edge in terms of types of products and technologies offered and under development. The last 30 years has seen the biopharm boom, and most recently, the marriage of therapies with high-tech delivery systems, particularly prefilled syringes and other injection devices.

  • How To Live With Uncertain Pharma Demand Forecasts
    How To Live With Uncertain Pharma Demand Forecasts

    Demand forecasts are often wrong because they are developed to inform manufacturing commitments as many as four to five years before product launch. As contractual relationships with CMOs are driven by forecasts inaccurate forecasts can “result in unfavorable pricing, financial penalties, and inappropriate capacity,” according to Jim Miller, President of PharmSource, a pharmaceutical industry contract manufacturing intelligence firm.

  • Integrating Quality Control Tools Into Print Workflow Automation Solutions
    Integrating Quality Control Tools Into Print Workflow Automation Solutions

    For print professionals, the complexities of labeling and packaging can present numerous challenges. Ask any member of a prepress department and they will tell you that artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

  • 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
    3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

  • Four Steps To Conducting A Successful Data Integrity Audit
    Four Steps To Conducting A Successful Data Integrity Audit

    Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills.

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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