• 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.

More From Our Editors


  • A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13
    A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13

    As I hope you will see in this article, A Tale of Two Annexes would actually start “It was the best of times, it was almost the worst of times.” And that is because the two courses eventually taken by the agency were actually the best outcomes for the two annexes.

  • Biosimilar Discounting & Contracting: What Can The U.S. Learn From Europe?
    Biosimilar Discounting & Contracting: What Can The U.S. Learn From Europe?

    Based on our research, the European Union (EU) is 10 years ahead of the United States with respect to biosimilar adoption. It is therefore unsurprising that the EU’s actions and policy decisions are having an impact on the U.S. market. In this two-part series, we will consider multiple facets of the EU’s influence. Part 1 will focus on payer coverage of biosimilars and the role of discounting and contracting. Part 2 will highlight the effects of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

  • How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned
    How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned

    When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.

  • The Value Of Standardizing Risk Assessment Across Quality Systems

    In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.

  • Using Lean Strategy To Improve Efficiency In Pharmaceutical QC Labs

    The QC lab is often seen as outside of the pharmaceutical production process, and, as a result, opportunities for improved efficiency and operational excellence are missed. A major source of complexity and poor utilization of resources is often lab throughput time — the time between the arrival of a test sample in the lab, completion of testing, and release of the data.

More From Guest Contributors


  • Test Parameters For The Leak Test Of Single-Use Systems With The Palltronic® Flowstar LGR Instrument

    Leak testing of SUS or biocontainers, post-installation and prior to actual use, reduces the risk that a system or a biocontainer which may have been damaged during shipping, receiving, handling, storage, or installation could contribute to valuable product loss. Therefore, in cases involving high value product or complex multiple operations, leak testing may be recommended prior to use at the end-user site. This document serves to provide general guidance for experimentally establishing leak test maximum  flow for SUS tested at the end-user site. It is intended to assist users in the development of parameters and maximum flow for the leak test of single-use systems when using the Palltronic Flowstar LGR test instrument.

  • Modular Does Not Always Mean Flexible For Pharmaceutical Facilities

    Flexible facility designs are often discussed in the same breath as modular designs. The two terms aren't interchangeable and are not even always that closely connected.

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Cleaning Validation – Lessons Learned in the Trenches March 28, 2018
1pm-2:30pm EST, Online Training
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