Authors




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.



Isha Bangia, PharmD, MBA

Latest:

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

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:

Employer Playbook Suggests Strategies for Biosimilar Adoption, Navigating Adalimumab Launches

A new resource from the National Alliance of Healthcare Purchaser Coalitions aims to help plan sponsors adopt biosimilars into their pharmacy benefit plans.


The Center for Biosimilars Staff

Latest:

Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges

Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.


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 Do’s and Don’ts of Adding Novelty to Biosimilars Development

In his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.


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.






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.


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