Newsletter | December 19, 2019

12.19.19 -- Biosimilar Development Top 10 Of 2019


As we near the close of another eventful year, it’s worthwhile to reflect upon the major challenges, trends, and learnings that emerged in the biosimilar industry over the past year. This Top 10 Newsletter showcases the most popular articles published in Biosimilar Development in 2019. As this lineup of articles reveals, 2019 was a year of increasing competition, proactive government policies, and critical regulatory pathway adjustments. As is to be expected in a growing market, however, questions and concerns remain about proposed or existing policies, continued barriers to market access, and regulatory pathway inefficiencies.

I hope you find this year-end review both thought-provoking and beneficial — and that you have a wonderful holiday season. If you have any ideas for future editorial coverage, or are interested in submitting your own content, please email me. I would love to hear from you.

Thank you, as always, for your continued readership and participation in this crucial industry!

Anna Rose Welch, Editor

Top 10 Guest Columns
  1. Biosimilars And The BPCIA: Past, Present, And Future
    By Ha Kung Wong and April Breyer Menon, Venable Fitzpatrick
  2. Biosimilars Pipeline Shows Remarkable, Sustained Growth
    By Ronald A. Rader, BioPlan Associates, Inc.
  3. How Healthy Is The Biopharma Pipeline Heading Into 2019?
    By Eduardo Schur and Rares Barbu, Navigant
  4. What Is Skinny Labeling — And Will It Work For Biosimilars?
    By Limin Zheng, Ph.D., GCA Law Partners LLP
  5. Trends In Single-Use System Adoption In The Biopharma Industry
    By Ilene Roizman, BioPlan Associates, Inc.
  6. Medicare's International Pricing Index: Biosimilar Stakeholders Weigh In
    By Stanton R. Mehr, content director, Biosimilars Review & Report
  7. Increasing Biosimilar Competition: Trends In Government Responses
    By Elaine Blais, Nicholas Mitrokostas, and Khurram Naik, Goodwin Procter LLP
  8. Biosimilar Automatic Substitution In The EU5: Current State And Future Outlook
    By Marta Delgado, Ph.D., Decision Resources Group (DRG)
  9. Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight
    By Doug Robinson, principal, Harness Dickey
Top 10 Industry Insights
  1. Improved Process Economics Of Humira Biosimilar Purification
    By R. Drevland, C. Pratt, P. Khandelwal, L. Moriarty, and E. Jordan Dreskin, Bio-Rad Laboratories
  2. How Biopharma Is Capitalizing On The Antibody Boom
    By Günter Jagschies, GE Healthcare Life Sciences
  3. Is Your Biologic At Risk For Protein Aggregation? Part 1
    By Martin Gonzalez, Ph.D., Pfizer CentreOne Contract Manufacturing
  4. Prepare For An FDA Bioburden Inspection
    By Anastasia G. Lolas, M.Sc., Visionary Pharma Consulting LLC
  5. Purification Of Antibodies With Hydrophobic Anion Exchange Resin
    By X. He, L. Vang, M. Syder, P. Khandelwal, and D. Yoshikawa, Bio-Rad Laboratories
  6. Keys To Consistent Bioprocessing
    By Serena Fries Smith, Thermo Fisher Scientific
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