• 2018 Outlook: Biosimilar Trends To Watch
    2018 Outlook: Biosimilar Trends To Watch

    Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

DIA Biosimilars Conference Reveals “More Questions Than Answers”

During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

More From Our Editors


  • Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations
    Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.

  • 4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products
    4 Steps For Successful Tech Transfer Of Gene And Cell Therapy Products

    As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture, the requirement for the technology transfer of these products will only increase. This technology will transfer from smaller or academic establishments and development laboratories, to larger facilities with greater capacity in-house, or to a partner company or CMO. It can occur at any phase of a product’s life cycle, from R&D preclinical stages to post-Phase 3 clinical trials to full commercial production.

  • Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria
    Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria

    The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin.

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

  • Renovating An Existing Biotech Plant To Accommodate A Higher-Titer Product

    Over the last few years, we have discussed various design approaches and compliance trends. In this article, we will tackle a design problem that typically emerges in a mature production organization.

More From Guest Contributors


  • Modular, Flexible, Or Both? Keys To Biomanufacturing Facility Design

    In addition to traditional brick-and-mortar facilities, there are a range of alternative facility designs, including modular container, modular stick-built, isolator, and autonomous cleanroom POD designs

  • For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.

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Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
1pm-2:30pm EST, Online Training
cGMP Compliance - Understanding The Top Drug Enforcement Trends February 6, 2018
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response February 13, 2018
1pm-2:30pm EST, Online Training
Aseptic Process Simulations – A Comprehensive Guide for Proper Execution February 21, 2018
1pm-2:30pm EST, Online Training
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