Peter Page


Another European Study Finds SB4 Tolerated by Most Patients

The study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.

Christine Potkul


Lupin Partners With Mylan on Etanercept Biosimilar

Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.

Will Gatziolis, MBA


COVID-19's Multifaceted Effect on Biosimilars

The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.

Maggie L. Shaw


Dr Andre Harvin Answers How Oncologists Can Work to Expand Access to Biosimilars

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.

Kelly Davio


Using Biosimilar Filgrastim May Lead to Shorter Hospitalization, Lower Cost in PBSC Mobilization

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

Surabhi Dangi-Garimella, PhD


Federal Perspective on the Biosimilar Influence on Drug Costs

Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.

Sophia Z. Humphreys, PharmD, MHA


Contributor: The US Biosimilar Market Outlook for 2023

Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.

Mary Caffrey


Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.

Deana Ferreri, PhD


Summary of VOLTAIRE-X Study Explains Decision Behind Cyltezo Interchangeability

Cyltezo (adalimumab-adbm) was the first adalimumab biosimilar—and second biosimilar overall—to receive an interchangeability designation from the FDA.

Sonia T. Oskouei, PharmD, BCMAS, DPLA


Opinion: Is the Ophthalmology Market Ready to Embrace Biosimilars?

Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.

Stacie Ropka, JD, PhD


Opinion: Purple Book Patent Listings Are Only a First Step

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

Gregory F. Schimizzi, MD


Biosimilar Nonmedical Switching Must Never Undermine Patient Safety

While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.

Isha Bangia, PharmD, MBA


Contributor: Drug Delivery Devices Help Originator Companies Retain Market Share

Amgen's Onpro autoinjector device for pegfilgrastim is a stunning example of how product differentiation via drug delivery devices can protect market share in the biologics market.

Marj P. Zimmerman, BSPharm, MS, Stanton R. Mehr


Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in the Pipeline

Pegylated version (pegfilgrastim) Neulasta® is the more commonly prescribed agent, with a significantly longer half-life than its predecessor and is the preferred in patients receiving cancer chemotherapy.

Laura Joszt


Biosimilar Substitution Can Reduce TCOC, Improve Provider Performance in Value-Based Payment Models

A simulation study estimated the impact of biosimilar substitution on total cost of care (TCOC) and provider financial performance in the final performance period of the Oncology Care Model.

The Center for Biosimilars Staff


Quiz: How Well Do You Know These Biosimilar Policy Essentials?

Test your knowledge of major biosimilar policies, including challenging regulatory frameworks from around the world.

Jaime Rosenberg


Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name Drugs

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.

Theodore Bosworth


Phase 3 Study Confirms Clinical Equivalence for ABP 980 and Reference Trastuzumab

Complete phase 3 data show that a biosimilar almost beat reference trastuzumab (Herceptin) for the primary endpoint of pathologic complete response in patients with HER2-positive early breast cancer.

Sarfaraz K. Niazi, PhD


BioRationality: Biosimilar Steaks Turn into $3 Billion Mistakes

Similar to his piece on biosimilar whiskeys, Sarfaraz K. Niazi, PhD, takes on biosimilar steaks, which could be made using bioreactors to make affordable beef without harming animals, in his latest column.

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