Authors




Ron Lanton

Latest:

New Rule: Transition to BLA Pathway Is Complete

As of today, the FDA has completed a 10-year process to bring a wider set of biologics under the biologics license pathway for approval.





Stan R. Mehr

Latest:

Drug Couponing: Better or Worse for Biosimilars?

Payers will have to carefully mull limited options.




Scott Kniaz, 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.


Peter Page

Latest:

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

Latest:

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

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.


Maggie L. Shaw

Latest:

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

Latest:

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

Latest:

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

Latest:

Resources for Patients and Providers on Adalimumab Biosimilars

Expert providers in inflammatory diseases provide additional resources on biosimilars and adalimumab biosimilar for patients and providers.



Mary Caffrey

Latest:

PBMs Drive Up Drug Costs, Squeeze Out Generics and Biosimilars, FTC Report Finds

A long-awaited report from the Federal Trade Commission (FTC) finds that vertical integration and consolidation have worked against consumers and independent pharmacies.


Deana Ferreri, PhD

Latest:

Similar Persistence Rates Between Adalimumab New Starts, Switched Patients

A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.


Sonia T. Oskouei, PharmD, BCMAS, DPLA

Latest:

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

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.



Gregory F. Schimizzi, MD

Latest:

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.


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