• Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs
    Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

    Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

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.

More From Our Editors


  • Using Preliminary Hazard Analysis To Determine Equipment And Instrument Requalification Frequency
    Using Preliminary Hazard Analysis To Determine Equipment And Instrument Requalification Frequency

    Using a risk management tool such as preliminary hazard analysis, a periodic review frequency can be identified and applied to qualified equipment. This will enable a timely review of the equipment by means of pertinent data such as manufacturing performance trend data, change history, and/or deviation history to confirm consistent production results meeting the predetermined acceptance criteria.

  • How To (Better) Identify And Analyze Manufacturing Trends In Your GxP Organization
    How To (Better) Identify And Analyze Manufacturing Trends In Your GxP Organization

    This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)

  • Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies
    Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies

    The FDA has been issuing guidance documents addressing gene therapy development issues for approximately 20 years — a remarkable dedication of resources to an area that did not have a licensed product until 2017. Of the six gene therapy-related draft guidances the agency issued last month, two represent the first of the “suite of disease-specific guidance documents on the development of specific gene therapy products” Commissioner Scott Gottlieb promised in Dec. 2017. 

  • Manual Aseptic Processing: The Last Resort Or The Best Approach?

    When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.

  • 4 Future Scenarios For Cell And Gene Therapy Adoption

    Cell and gene therapies are finally becoming a reality, with hundreds of clinical trials underway and some major therapeutic breakthroughs already reaching the market. In the past year alone, the FDA approved its first gene therapy, Spark’s Luxturna for the treatment of a rare form of vision loss, as well as the first two CAR T-cell therapies, Novartis’s Kymriah and Gilead’s Yescarta, for certain forms of blood cancer. While this certainly marks the beginning of an exciting period in the development of cell and gene therapies — the culmination of decades of development — the future impact of cell and gene therapies is uncertain.

More From Guest Contributors


  • Test Parameters For The Leak Test Of Single-Use Systems With The Palltronic® Flowstar LGR Instrument

    Leak testing of SUS or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer which may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss. Therefore, in cases involving high value product or complex multiple operations, leak testing may be recommended prior to use at the end-user site. This document serves to provide general guidance for experimentally establishing leak test maximum  flow for SUS tested at the end-user site. It is intended to assist users in the development of parameters and maximum flow for the leak test of single-use systems when using the Palltronic Flowstar LGR test instrument.

  • Managing Demand Uncertainty In Biologics Production

    How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

More Bioprocessing White Papers


More Industry Insights


4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response August 22 - 22, 2018
1pm-2:30pm EDT, Online Training
More Industry Events