Authors






Gianna Melillo

Latest:

Coherus Banks on 2022 Approvals After Net Losses for Q4, 2021

Coherus released its earnings report for the last quarter of 2021 and for the year as a whole.


Marcus H. Snow, MD

Latest:

Dr Marcus H. Snow: The US Launch of Renflexis

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.


Allison Inserro

Latest:

FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).


Stanton R. Mehr

Latest:

Ritumixab Biosimilar Demonstrates Positive Results in Rheumatoid Arthritis

Pharmacokinetics of CT-P10 were highly similar to originator products.


Chad Landmon, 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).


Sara Karlovitch

Latest:

What's Ahead for Biosimilar Litigation?

What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation.


Christina Corridon, MPH, MBA

Latest:

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.


Daniella Latham

Latest:

Naming Biosimilars: The Debate Rages On

As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.


Jackie Syrop

Latest:

Study Finds ABP 215 and Bevacizumab Demonstrate PK Similarity in Japanese Men

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.





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.




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.


Prateek Yadav, MPTh, MBA

Latest:

The Next Frontier: Oncology Biosimilars in 2025 and Beyond

The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.


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.

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