EDITOR'S DESK

  • 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.

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GUEST CONTRIBUTORS

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
    How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

  • How Are Cell And Gene Therapies Changing Drug Development Models?
    How Are Cell And Gene Therapies Changing Drug Development Models?

    The biotechnology sector has seen important progress in the development of groundbreaking therapies in recent years, especially in the areas of immunotherapy and cell and gene therapy. In gene therapy alone, there are now clinical research programs targeting almost 50 different indications, up from only 10 a few years ago, and the rate of innovation is expected to continue to increase in the years ahead. A range of factors — including small patient populations, complex manufacturing processes, and lack of specialized expertise — are positioned to both drive up costs and require new options for stakeholder engagement and risk sharing along the development pathway. New approaches in development are needed to support the next generation of novel drugs on the horizon.

  • Regulators, Standards Groups Address Emerging Tech In Biopharma
    Regulators, Standards Groups Address Emerging Tech In Biopharma

    Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.

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BIOPROCESSING WHITE PAPERS

  • How To Choose The Right Connector For Your Biopharm Application

    With so many connection options, it can often be an overwhelming task to decide which connector is best suited for a specific application. By understanding your application requirements and selecting the correct connection type, you will have better performance and sealing results. By Colder Products Company

  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences

    The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training
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TRAINING COURSES

Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training
More Upcoming Courses