Tony Hagen is senior managing editor for The Center for Biosimilars®.
Study: OCM Reduces Use of Some Supportive Care Medications and Boosts Filgrastim Biosimilar Use
Investigators noted a reduction in use of high-cost supportive care agents, suggesting that the value-based Oncology Care Model (OCM) is working.
Ogivri Equivalence Demonstrated in Neoadjuvant HER2+ Comparative Trial
Investigators further elucidate the equivalence of a trastuzumab biosimilar vs Herceptin in human epidermal growth factor receptor 2–positive (HER2+) breast cancer.
Study Suggests Oncologists' Use of Biosimilars Grew From Trickle to Flood
When biosimilars emerged in oncology, oncologists dipped in a toe and then got serious, according to a retrospective study on usage and savings presented at ASCO 2021.
Texas Oncology Reports Savings From Biosimilar Substitution Effort
The substitution program was carried out in 2020 and yielded savings of $4 million in 1 month, investigators reported at ASCO 2021.
News Roundup: Organon Starts Life as a Biosimilars Marketer
Organon will do marketing but not research and development, Biogen and Bio-Thera move forward with tocilizumab candidate, and Lupin promotes a pegfilgrastim biosimilar.
French Investigators Report Rituximab Immunogenicity Findings
Immunogenicity was rare but concerning for patients who switched from originator rituximab to the biosimilar Riximyo, investigators reported.
Poster Roundup: Results Presented for Samsung Bioepis Biosimilars for Adalimumab, Infliximab
Real-world clinical data compiled for patients with autoimmune disorders were presented at EULAR 2021.
Celltrion Supports High-Concentration Adalimumab Biosimilar Launch With Phase 3 Trial Data
Celltrion announces the launch timing for its much anticipated high-concentration formulation of adalimumab and presents trial data supporting equivalence to the reference product.
Pharmacy Economist Describes Fork in the Road for Generics and Biosimilars
Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.
Medicines for Europe Panel Targets Inefficiencies, Need for Education
More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.
Zydus Cadila Launches Trastuzumab Emtansine Biosimilar
An antibody conjugate, Ujvira combines the cancer cell growth–fighting properties of trastuzumab with the cytotoxic capability of emtansine.
Infliximab Study Yields Evidence of Biosimilar Equivalence
Adjusting for variables, investigators found little difference in disease outcomes for patients who switched to the infliximab originator vs biosimilars.
Prestige BioPharma Plans Investment to Boost Its Drug Pipeline
Prestige BioPharma aims to expand its drug pipeline with a $152 million research and development facility.
Sandoz Panel Describes Issues, Opportunities for Biosimilars
Biosimilar education can increase physician motivation to prescribe these alternatives to costly originator products, panelists said in a Sandoz/Reuters discussion.
AbbVie Study Highlights Switching Costs for Rheumatic Biosimilars
A study funded by AbbVie finds support for maintaining patients on originator rheumatic agents, such as Humira (adalimumab), rather than switching to biosimilars.
Quebec Makes It Harder to Use Originator Biologics
Biosimilars were on formulary for years but nobody was using them, Canadian authorities explain as their reasons for dropping originators from approved lists.
AbbVie's Gonzalez Is on Defense as House Members Petition FTC
Accused of unfair trade practices, AbbVie's CEO Richard Gonzalez pointed the finger at Medicare Part D.
House Committee Issues Blistering Report on AbbVie's Humira Tactics
The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination.
Sandoz Is 0-3 in Enbrel Patent Case
Originator company Amgen has won another round in defending its lucrative etanercept franchise, but the decision is sure to intensify scrutiny of extended patent protections.
German Study Calculates Adalimumab Biosimilar Savings From Earlier Intervention
Investigators evaluated both biosimilar vs originator savings and savings from earlier use of a lower-cost adalimumab biosimilar (Amgevita).
Biosimilars News Roundup: BLA Tailoring, Medicare 5-Star Ratings
Streamlining of biologics license applications (BLAs) in Britain is now official, and in the United States, legislators propose a ratings system to promote biosimilars.
Samsung Bioepis Executive Reflects on Interchangeable Designation
A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.
Coherus Aims to Chip Away at Onpro Dominance
With COVID-19 on the retreat, Coherus BioSciences sees the advantage wearing off for Amgen's pegfilgrastim injector kit.
Alvotech Files Suit to Invalidate Humira Patents
After being sued for allegedly stealing adalimumab process information, Alvotech fires back.
US, EU Regulators Discuss Tailoring Biosimilar Approvals
During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for tailored approach to bring biosimilars to market sooner with less expense and wasted effort.
Regulators Look Back on 15 Years of Biosimilars in Europe
Advances in analytical testing have improved confidence in biosimilars, according to a Medicines for Europe panel.
Pfizer and Organon Provide a Glimpse of Biosimilars Strategy
Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of this planned Merck spinoff.
The Difference Between an Interchangeable Biosimilar and One That Isn't
The anatomy of an interchangeability switching study.
Sandoz to Start Phase 3 Trial of Aflibercept Biosimilar
There are multiple contenders now in the race to bring the first aflibercept (Eylea) biosimilar to market in the United States and European Union.
AbbVie CEO Is on Deck as Antitrust Hearings Heat Up
Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.