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

  • Microfluidizer Processor Helps Increase The Odds Of Drug Discovery At Tularik Tularik Inc. (South San Francisco, CA) uses the Microfluidizer as a critical part of its protein harvesting operation. The company was recently profiled in the New York Times as representative of a new trend in drug discovery: to perform tests, called assays, that show how target substances, like proteins, respond to different chemical compounds in environments that mimic the conditions of a living cell. Submitted by Microfluidics
  • The Reputational Risk Of Poor Cold Chain Visibility

    In India, the cold chain logistics sector is getting ready for the growing number of large multinational corporations providing their global brand products in India. Several new state-of-the art cold storage warehouses and logistics operations are emerging, to help these international food and pharmaceutical companies to maintain product quality, and ultimately, their global reputation.

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INDUSTRY INSIGHTS

  • Streamlining Recombinant Protein Production
    Streamlining Recombinant Protein Production

    Use of recombinant proteins as therapeutics has become an attractive strategy for altering the biology of disease progression and offers significant commercial opportunities.  However, bringing a recombinant protein to market requires a substantial investment of time and resources, and the process is generally complex and subject to technical pitfalls.

  • The CAPA Detective
    The CAPA Detective

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

  • Improve Operations, Collaboration, And Time-To-Market: The Digital Lab
    Improve Operations, Collaboration, And Time-To-Market: The Digital Lab

    Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations.

  • Impact Of Incorrect Forecasts On New Drug Product Launches
    Impact Of Incorrect Forecasts On New Drug Product Launches

    Pharmaceutical company marketing executives have become more accurate in positioning their new product in the marketplace, profiling prescribers, and understanding and responding to the reimbursement landscape. What is still a quagmire for pharma companies is predicting the actual demand for products and the timing of that demand.

  • As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry
    As Largest Precision Medicine Trial in Oncology Launches, Questions Remain for Industry

    Over the last few days at ASCO, multiple studies have shown the remarkable potential of matching cancer therapeutics to specific gene mutations, demonstrating that we are truly entering an age of personalized medicine in oncology. Despite all of the promise, the conference discussions also covered many questions yet to be resolved – by academic centers and pharmaceutical companies, doctors, patients and those of us working in the lab.

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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