EDITOR'S DESK

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

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

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GUEST CONTRIBUTORS

  • An Approach And Checklist For Engineering Due Diligence In Pharma M&As
    An Approach And Checklist For Engineering Due Diligence In Pharma M&As

    The pharmaceutical industry has evolved dramatically over the past 40 years, constantly changing the manufacturing environment to accommodate products, processes, efficiencies, equipment development, and compliance. All of the companies have changed, and today they more frequently analyze their product portfolio, manufacturing business, and facility efficiencies to rationalize their manufacturing scheme. In addition, the steady rise of contract manufacturing firms has added another dimension to the pharmaceutical manufacturing equation, as those plants expand and renovate to attract and accommodate new manufacturing capability.

  • An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market
    An Analysis Of Regulatory Reforms In China’s Pharmaceutical Market

    Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.

  • 6 Public Policy Changes To Ensure A Competitive Biosimilar Market
    6 Public Policy Changes To Ensure A Competitive Biosimilar Market

    Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.

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BIOPROCESSING WHITE PAPERS

  • How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  • 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

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INDUSTRY INSIGHTS

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