How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?
How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?

A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.

  • Biosimilars Pipeline Shows Remarkable, Sustained Growth
    Biosimilars Pipeline Shows Remarkable, Sustained Growth

    The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress. 

  • Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  • One Issue Tailor-Made For Biosimilar Maker-Employer Collaboration
    One Issue Tailor-Made For Biosimilar Maker-Employer Collaboration

    In the first of what will be a two-part article, I’ll share two employer organization experts' thoughts on current reimbursement models for biosimilars and how employers and manufacturers can to reshape these practices to bring biosimilars more regularly into employer negotiations.      

  • Recent Reimbursement Policies Aim To Shake Up Biologics Buy-And-Bill
    Recent Reimbursement Policies Aim To Shake Up Biologics Buy-And-Bill

    As policy makers release new policies to reduce healthcare spending, it’s imperative that biosimilar companies emphasize that lowering drug prices and cutting reimbursement are not the same thing. The latter could have serious consequences for critical classes of medicines, including biosimilars.   

  • FDA Approval Of The First nr-AxSpA Biologics: Projecting Regulatory & Market Dynamics
    FDA Approval Of The First nr-AxSpA Biologics: Projecting Regulatory & Market Dynamics

    Although we expect the FDA approval of therapies for non-radiographic axial spondyloarthritis (nr-AxSpA) to be an important event in the coming year, questions remain about the U.S. market potential. Because three therapies are expected to be approved within a similar timeframe, any first-to-market advantage may be limited.

  • Two Biosimilar Policies Raise Questions About Reimbursement Consistency
    Two Biosimilar Policies Raise Questions About Reimbursement Consistency

    In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

  • Biosimilar Success: It’s Not As Risky To Attain As We Think
    Biosimilar Success: It’s Not As Risky To Attain As We Think

    In the first of what will be two articles, I walk you through a high-level model forecast Engert shared to demonstrate that the value-capture possible after developing a biosimilar is much higher than what we may assume. In order to receive these rewards, however, there are five steps Engert outlines that a company must take to properly manage the risks that arise.

  • Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In
    Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In

    Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

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BIOSIMILAR INSIGHTS

  • End-To-End Process For Oncolytic Adenovirus Production

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  • Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System

    Using rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using a rocking bioreactor system.

  • BsAbs: Save Time With One-Step Purification

    Bispecific antibodies (BsAb) can, in early screening phases, be purified using protein A chromatography in a single step. In this study, BsAb constructs were efficiently purified using a one-step approach, saving 4 to 6 weeks.

  • 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. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.

  • The New Age Of Digital Biomanufacturing

    Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. This poster explains the drivers of the digital biomanufacturing revolution and how they are steering us towards science-based increased plantwide efficiency, quality, adaptability, and profitability.

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TRAINING COURSES

Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities March 27 - 27, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
17th Biosimilar Medicines Conference March 28 - 29, 2019
Amsterdam
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance April 4 - 4, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success April 9 - 9, 2019
1pm-2:30pm EST, Online Training
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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs April 11 - 11, 2019
Online Training; 1:00 - 2:30 PM EDT US
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Aseptic Process Validation: Top-Tips for Compliance and Success April 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Stability Programs – Key Factors in Meeting FDA/ICH Expectations April 22 - 22, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Instructional Design for GMP Training – Improve Effectiveness and Measurability April 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities March 27 - 27, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
17th Biosimilar Medicines Conference March 28 - 29, 2019
Amsterdam
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance April 4 - 4, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!

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