Authors



Erwin A. Blackstone, PhD

Latest:

Expect Shakeout Amid Biosimilar Market Growth

The biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.


The Center for Biosimilars Staff

Latest:

Patel: Biosimilar Education Can Be Challenging

Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.




Deana Ferreri

Latest:

Gastroenterologists Want More Evidence on Nonmedical Switching

Although the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.


Ron Lanton III, ESQ

Latest:

Election May Determine Pace of Biosimilar Legislation

There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.


Drew Hillier JD

Latest:

Legal Opinion: BPCIA Is Likely to Survive Latest ACA Challenge

Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).


Lindsey Mulrooney

Latest:

Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.


Jessica Mourani, PharmD

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.


Jeff Baldetti, MBA

Latest:

Opinion: How Will Semglee Interchangeable Insulin Affect Access and Affordability?

The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains.


Rebecca Clegg, JD

Latest:

Opinion: The Legal and Regulatory Year in Review

Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.


Gilbert T. Smolenski, JD

Latest:

What We Learned About Biologics on Summer Vacation

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.


Amber Skrtic, PharmD

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.


Scott Shields, MBA

Latest:

Opinion: Biosimilars Offer Savings and Access for US Patients

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.


Jeff Patton, MD
Jeff Patton, MD

Latest:

Contributor: No Good Deed Goes Unpunished—How PBM Mandates Increase Practice Variability

Jeff Patton, MD, CEO and board member at OneOncology, dived into the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.


April E. Weisbruch, JD

Latest:

What We Learned About Biologics on Summer Vacation

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.


Ivo Abraham, PhD
Ivo Abraham, PhD

Latest:

Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and Bioparallels

In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.


Luke Halpern

Latest:

The Growth of Biosimilars Continues to Create Hope for Lower Drug Costs

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.


Amanda O'Hora

Latest:

Opinion: Biosimilars Offer Savings and Access for US Patients

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.


Kathy Oubre, MS

Latest:

Contributor: The Promise of Biosimilars and the Harsh Reality of the US Market

In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.


Denise Myshko

Latest:

CVS Caremark Switches Up Biosimilar Coverage in 2024

As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.


Aaron Z. Savit, PhD

Latest:

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.


Joseph Park, PhD

Latest:

Confusion Persists Around the Interchangeability Designation for Biosimilars

The legal and common uses of “interchangeability” continue to be conflated.


Gillian Woollett, MA, DPhil

Latest:

Confusion Persists Around the Interchangeability Designation for Biosimilars

The legal and common uses of “interchangeability” continue to be conflated.


Dan Danielson, RPh, MS

Latest:

Contributor: What’s Behind the Slow Uptake of Biosimilars in the US?

Dan Danielson, RPh, MS, senior director, market access solutions, at PrecisionValue, a market access marketing firm, explains the remaining issues at play slowing down biosimilar uptake in the United States.


Alejandro Menchaca, JD

Latest:

The Inner Workings of the BPCIA Patent Dance

The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.


Kristi Rosa

Latest:

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.


University of Arizona R. Ken Coit College of Pharmacy

Latest:

Dr Ivo Abraham Column: Biosimilars and the Commoditization of Treatments

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores whether biosimilars should be considered a commodity and if the commodification of medications is sustainable as the market continues to expand.

© 2024 MJH Life Sciences

All rights reserved.