EDITOR'S DESK

  • How To Prepare Your Biosimilar Company For Interchangeability
    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.

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. 

More From Our Editors

GUEST CONTRIBUTORS

  • Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century
    Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century

    This article will be part of the CPhI 2016 Annual Report, which will be released during the CPhI Worldwide event in Barcelona (October 4-6, 2016).

  • 5 Steps To Build A Quality Culture That Supports Data Integrity
    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
    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.

  • FDA vs. EMA? A Review Of Recent EU Enforcement Actions In The U.S.

    The FDA and the European Union (EU) have taken serious enforcement actions against several firms in the other’s geographic jurisdiction during the calendar year 2016. Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours activity represents an unofficial test, of sorts, as these agencies move to rely more on each other’s inspections — though these recent actions may test the limits and validity of such mutual recognition.

  • Companion Diagnostics Leakage In Oncology — What Biopharma Companies Need To Know

    Biopharmaceutical companies continue to adopt personalized medicine approaches that leverage patient-specific biomarkers to stratify patients. Companion diagnostic (CDx) tests are indispensable to personalized medicine, which relies on accurate, reliable, and clinically meaningful tests to identify the appropriate drugs for each patient.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

Visual Inspection Week September 26 - 30, 2016
Bethesda, MD
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response September 27, 2016
1pm-2:30pm EDT, Online Training
The HireLifeScience.com Career Fair 2016 September 27, 2016
Edison, NJ
Introduction to Biostatistics: Collecting and Summarizing Data September 28, 2016
1pm-3pm EDT, Online Training
More Industry Events

TRAINING COURSES

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response September 27, 2016
1pm-2:30pm EDT, Online Training
Introduction to Biostatistics: Collecting and Summarizing Data September 28, 2016
1pm-3pm EDT, Online Training
New Pharma Compliant Google Ad Formats – Implementation Tips For Success September 29, 2016
1pm-2:30pm EDT, Online Training
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses