Authors

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BLA Resubmitted to FDA for On-Body Injector Presentation of Pegfilgrastim-cbqv

The biologics license application (BLA) seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of Neulasta Onpro, has been resubmitted to the FDA for review.

Tyler Sandahl, PharmD

Tyler Sandahl, PharmD, is a clinical pharmacist at Mayo Clinic.

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Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

Cameron Santoro

Cameron Santoro is an associate editor for The Center for Biosimilars

Latest:

Dulaglutide Biosimilar LY05008 Shows Efficacy and Safety in Treating Type 2 Diabetes

The dulaglutide biosimilar LY05008 demonstrated equivalent efficacy in reducing HbA1c, along with comparable safety and immunogenicity profiles, to the reference drug dulaglutide in Chinese adults with type 2 diabetes.

Marion Schauf, Dipl-Kff

Latest:

Budget Impact Analysis of Biosimilar Natalizumab in the US

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

St John Skilton, PhD

As vice president of product strategy and marketing, St John Skilton manages the new product development at Protein Metrics Inc. With deep domain experience in MS and related analytical tools the biopharmaceutical industry, Skilton has been at the forefront of development for many years.

Latest:

Contributor: The Biosimilars Wave Is Crashing on the Shores of Biopharma Development

St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.

Amber Skrtic, PharmD

Amber Skrtic, PharmD, CSP, AAHIVP, is Vice President of Trade Relations for CPS Solutions.

Latest:

Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?

Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

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Dr Ryan Haumschild Draws Link Between Biosimilars, Health Equity in Breast Cancer

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, discusses the growth and continued challenges facing biosimilars used to treat breast cancer.

Susan Trieu, PharmD

Susan Trieu, PharmD, is Senior Vice President of Specialty Clinical Strategy and Trend for CPS Solutions

Latest:

Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?

Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

Latest:

Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.

Jeannette Y. Wick, RPh, MBA, FASCP

Latest:

Learning the Lingo of Biologics and Biosimilars Is Critical

The number of FDA-approved biologics has exploded, and biosimilars are making their mark.

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