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

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • What You Need To Know To Avoid Costly Delays In Your API Scale-Up
    What You Need To Know To Avoid Costly Delays In Your API Scale-Up

    If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

  • Rapid Single–Step Purification Of Proteins From Whey
    Rapid Single–Step Purification Of Proteins From Whey

    Whey proteins play a vital role in the formulation of food supplements because of numerous desirable nutritional and functional properties. This case study depicts the establishment of a process workflow for whey purification using Nuvia S and Nuvia Q Ion Exchange Resins.

  • Solving The OOS Problem With Continuous Manufacturing
    Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  • Is Automation The Disruption Pharma R&D Needs?
    Is Automation The Disruption Pharma R&D Needs?

    Through the implementation of automation, data management, and analytical technologies, pharma has the opportunity to breathe new life into a number of areas of the biologics drug development process.

  • Speaking The Regulatory Language
    Speaking The Regulatory Language

    The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.

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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