GUEST COLUMNISTS

  • Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes
    Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  • Are Good Manufacturing Practices No Longer Good Enough?
    Are Good Manufacturing Practices No Longer Good Enough?

    Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

  • Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time
    Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  • Trends To Watch In China’s Biopharma Industry
    Trends To Watch In China’s Biopharma Industry

    China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

  • Intro To Prefilled Syringe Selection: Staked-In Needles
    Intro To Prefilled Syringe Selection: Staked-In Needles

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  • The Need For Enhanced Control Strategies In Biopharma Production
    The Need For Enhanced Control Strategies In Biopharma Production

    Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater. 

  • Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook
    Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

More From Our Guest Columnists

BIOSIMILAR WHITE PAPERS

  • Digital Manufacturing Of Biologics
    Digital Manufacturing Of Biologics

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

More Biosimilar White Papers
Anna Rose Welch article header

BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

19_07_BSD_USRegulatoryProgressEbook_300x200

 

Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This free collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.

More Content Collections

LIFE SCIENCE EVENTS

Establishing Appropriate Quality Metrics November 21 - 21, 2019
1pm-2:30pm EST, Online Training
Global Summit On Biosimilars December 3 - 4, 2019
Munich
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Specialty Therapies and Biosimilars Summit January 22 - 24, 2020
Miami, FL
More Events...