Authors



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

Latest:

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

Latest:

Fourth Ustekinumab Biosimilar, Otulfi, Approved in US

Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.


The Center for Biosimilars Staff

Latest:

Quiz: The US Biosimilar Regulatory System

Dive into biosimilar regulations in the US! Test your knowledge with our quiz on FDA rules, naming tricks, postmarket safety, and more. Ready for the challenge?


Jaime Rosenberg

Latest:

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

Latest:

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

Latest:

BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.


Samantha DiGrande

Latest:

AAM's Christine Simmon on Biosimilars Council Initiatives and Educating Around Interchangeability

After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.



Kaitlynn Ely

Latest:

Rituximab Induction Is Cost Effective for Asymptomatic Advanced Follicular Lymphoma

Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.


Joseph P. Fuhr, 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.


Christina Mattina

Latest:

Califf Wins Narrow Senate Vote for Second Turn as FDA Commissioner

In a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.



The Center for Biosimilars

Latest:

Novartis to Make Sandoz a Stand-alone Company

The move will create Europe's largest generics company.


Ross Shahinian

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.




Kashyap Patel, MD

Latest:

The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.



Sandeep Sangwan, MPharm

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.








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).

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