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.

More From Our Editors

GUEST CONTRIBUTORS

  • EMA’s Revised Format For Risk Management Plans – What You Need To Know
    EMA’s Revised Format For Risk Management Plans – What You Need To Know

    The revised format for the EU Risk Management Plan sets a new milestone in a progressive approach to risk management. The new RMP template is a straightforward and well-structured document that can be used by RMP experts, and the concepts behind risk management have been justified to better reflect the stages of the life span of a medicinal product.

  • Should You Rotate Disinfectants? Industry Experts Weigh In
    Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

  • Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?
    Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products

  • Regulatory GMP Expectations For Learning, Training, & Performance In Pharma/Biopharma

    Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.

  • How Mylan Used Partnering Deals To Become A Key Player In Biosimilars

    Mylan’s roots are firmly based in the small-molecule generics business; however, the company has positioned itself as a strong competitor in the biosimilar field with the help of key strategic partnerships in recent years. This article explains how the company expanded its access to different biosimilars and given it more rapid access to key biosimilar markets.

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BIOPROCESSING WHITE PAPERS

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Building An Effective GMP Training System: A Risk-Based Approach September 21 - 21, 2018
1pm-2:30pm EDT, Online Training
3rd Annual Lay Summaries Summit September 24 - 25, 2018
Philadelphia, PA
16th Annual Cold Chain Global Forum September 24 - 28, 2018
Philadelphia, PA
PAP Legal Update September 25 - 26, 2018
Arlinton, VA
Finance & Accounting for Bioscience Companies September 25 - 26, 2018
Boston, MA
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TRAINING COURSES

Building An Effective GMP Training System: A Risk-Based Approach September 21 - 21, 2018
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them October 8 - 8, 2018
1pm-2:30pm EST, Online Training
How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency October 16 - 16, 2018
1pm-2:30pm EDT, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations October 25 - 25, 2018
1pm-2:30pm EST, Online Training
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