Tony Hagen is senior managing editor for The Center for Biosimilars®.
Study: Nocebo Is Likely Cause for Reverse Switching in IBD
Three-fourths of patients who reverse-switched to originator infliximab from CT-P13 benefited, although it wasn't clear why the biosimilar treatment "failed."
Roche's 2020 Losses to Biosimilars Were "Worst It Can Get"
Biosimilar competition took a big chunk of revenue from Roche's aging blockbusters in 2020, and the company is banking on its newer medicines to drive fresh revenue growth.
Study: Biosimilar Use Varies by Type of Institution and Physician Characteristics
Physician specialty and practice setting each play a significant role in whether biosimilars are administered vs originators, according to a large, cross-sectional study.
Celltrion Gains Canadian Nod for Subcutaneous Infliximab
Celltrion aims to try a direct marketing approach in Canada to streamline sales of its subcutaneous form of Remsima.
Amgen Profits Get a Ride on Biosimilar Growth
Amgen described how a double-edged biosimilars sword has worked for and against the company's profit margin.
Pfizer Biosimilar Revenues Top $525 Million in Fourth Quarter 2020
Pfizer's investment in biosimilars is starting to pay off, as it now ranks these agents among its top revenue drivers.
Magellan Rx Reports Step Therapy Is Workhorse in Biosimilar Utilization
The pharmacy benefit manager reported 90% biosimilar uptake among its health plans that adopted clinical management policies that included step therapy or parity usage.
FDA Accepts Bio-Thera's BLA for Bevacizumab Biosimilar
Guangzhou, China-based Bio-Thera has filed a biologics license application (BLA) with the FDA for the approval of bevacizumab biosimilar candidate BAT1706.
Vizient Predicts 7.5% Humira Price Increase Before Biosimilars Arrive
In its annual drug price guide, Vizient predicts that US annual adalimumab (Humira) revenues could reach $24 billion before biosimilars enter the marketplace.
Nurses Can Counter Nocebo Effect in Biosimilar Switching
The study of originator infliximab and SB2 used nurses as the first point of contact when educating patients, relying partly on patient trust in these health care professionals.
China Pulls Out Stops for Biosimilar Development
It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.
Coherus CEO Discusses Post–COVID-19 Growth Prospects
Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.
Prestige Biopharma Plots Biosimilar Growth Strategy
Biosimilars will be the cornerstone for a leap into biologics development and commercialization, according to the CEO of Prestige Biopharma. Also, Innovent Biologics reaches a marketing agreement.
Investigators Study Risks of Hypertension, Proteinuria With Bevacizumab
The study was designed to elucidate incidence of hypertension and proteinuria in patients treated with bevacizumab reference vs biosimilar products.
Swift Uptake for Mvasi Suggests Provider Comfort With Use
Investigators looked at the first 9 months of use following the launch of the bevacizumab biosimilar Mvasi to gauge physician comfort with this agent across tumor types.
IGBA, Celltrion, Others Mark Biosimilar Advances
The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.
With New Policy, CMS Promises to Exit "Stone Age" of Health Information
CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests.
Hill Describes Supercharged Biologics Market in China
Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.
Data From HERITAGE Confirm PK Biosimilarity for Ogivri
Pharmacokinetic (PK) parameters matched up with those of reference trastuzumab in an extended analysis of data from the HERITAGE trial.
Economists Probe Cost-Effectiveness of Biosimilars
Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.
Adalimumab Biosimilars Face Product Obsolescence Before Launch
Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.
Investigators Chart ABP 980 Biosimilar Uptake in European Clinics
Among patients treated for metastatic breast cancer, 40% switched to ABP 980.
Alvotech Breaks Ground for Biosimilar Development Facility
An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.
Innovent Biologics Gains NMPA Approval for Additional Sulinno Indications
China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.
Opinion: The Year Ahead in Biosimilar Potential
Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.
CfB Board Members Reflect on Year in Biosimilars
Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.
A Review of the Most-Read Biosimilar Stories of 2020: Part 2
In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020.
Pandemic Delays FDA Decision on Biocon's Bevacizumab Application
MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.
A Review of the Most-Read Biosimilar Stories in 2020: Part 1
The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape.
Amgen's Bourdon Discusses Riabni Rollout in the United States
Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.