Study: Machine Learning Could Optimize Biosimilar Therapy
Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy.
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.
The Top 5 Biosimilar Articles for the Week of January 4
Here are the top 5 biosimilar articles for the week of January 4, 2021.
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.
Reviewers Consider "Totality of Evidence" for Mvasi
Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.
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.
The Leading “Not So Different” Podcast Episodes of 2020
Here are some of our most-listened-to 2020 "Not So Different" podcasts.
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.
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.
The Most-Popular Center for Biosimilars® Interviews of 2020
Here are some of our most-popular biosimilar interviews for all of 2020.
Opinion: The Legal and Regulatory Year in Review
Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.
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.
AMCP Sets a Course for Biosimilar Promotion
A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.
Bio-Thera Seeks to Enter Brazilian Market for Bevacizumab
Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.
Samsung Bioepis Examines European Awareness of Biosimilars
In the EU-5 group of countries, biosimilar awareness is poor, hindering uptake of these potentially cost-saving medicines, a white paper states.
Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar
The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.
The Top 5 Biosimilar Articles for the Week of December 14
Here are the top 5 biosimilar articles for the week of December 14, 2020.
FDA Approves Rituximab Biosimilar "Riabni" From Amgen
The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.
Policy Review Cites Need for Regulatory Clampdown on Pay-for-Delay Tactics
An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.
Samsung Bioepis Initiates Phase 3 Trial for Denosumab Biosimilar
Samsung Bioepis hopes to gain regulatory approval for a denosumab biosimilar referencing Prolia. The trial will focus on women with postmenopausal osteoporosis.
Investigators Demonstrate Dramatic Rise in Trastuzumab Biosimilar Use
In little over 1 year of use in patients with breast cancer, trastuzumab biosimilars have seen rapid growth in uptake.
Biocon/Mylan Receive CHMP Nod for Insulin Aspart Biosimilar in European Union
The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be followed by a European Commission final decision early in 2021.
Australian Biosimilar Trade Group Names New Chair
Health care policy expert Jane Halton, AO, PSM, has been picked for her extensive experience in governmental health affairs.
Celltrion's CT-P17 Gains CHMP Recommendation for EU Marketing
The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate.
The Top 5 Biosimilar Articles for the Week of December 7
Here are the top 5 biosimilar articles for the week of December 7, 2020.