Tony Hagen is senior managing editor for The Center for Biosimilars®.
AmerisourceBergen Rep Previews the Year Ahead for Biosimilars: What’s Coming Down the Pipeline in 2022?
Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.
Industry Group Representative Discusses Biosimilars in Michigan
Bret Jackson, president of the Economic Alliance for Michigan, notes that Ford Motor is a biosimilar success story, having saved a significant amount of money on just a handful of drugs.
International Biosimilars Trade Group Appoints New Leadership for 2022
The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.
Michigan Trade Group Outlines Best Practices for Biosimilar Adoption
Ford Motor saved $5 million by switching patients to 5 biosimilars, and other manufacturers and employers in Michigan have achieved good results with switching programs, the Economic Alliance of Michigan reports.
Robert Popovian, PharmD, MS, Discusses Biosimilar Progress and Education in the United States
As chief science policy officer for Global Healthy Living Foundation, Robert Popovian, PharmD, MS, has a bird’s-eye view of some of the central issues of biosimilar access in the United States.
Amgen CEO Touts Potential for Doubling in Biosimilar Revenue
Amgen Chairman and CEO Robert Bradway touted the potential of 11 biosimilars anticipated to be driving revenues for the company by 2030.
Canada Clears Alvotech Adalimumab Biosimilar for Launch
Simlandi (AVT02) is the second high-concentration, citrate-free adalimumab (Humira) biosimilar to be approved in the Canada market.
In India, Patient Advocates Lobby for Modernized Biosimilar Development Standards
In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.
Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology
Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write.
Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab
The companies hope to gain FDA approval for a high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar that was approved in a lower concentration in July 2019.
Biosimilar Savings Through 2025 Could Total $38.4 Billion
Savings from adalimumab biosimilars, which won't enter the US market until 2023, account for a significant share of the total, investigators said.
Report: Biosimilar Competition in Europe
Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.
The Top 5 Biosimilars Legal Stories of 2021
The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.
Biosimilar Legal and Business Developments in 2021
The Center for Biosimilars® spoke recently with Chad Landmon, chair of the Intellectual Property and Food and Drug Administration Practice Groups at Axinn, a New York–based antitrust, intellectual property, and litigation law firm.
Highly Confident, Biosimilar Companies Notch Global Commercialization Deals
With fewer of the risks associated with novel drug development, biosimilar candidates allow manufacturers to plan far into the future for marketing needs.
In Canada, More Mandatory Switching
In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.
2021 Was an "Inflection Year" for Biosimilars
The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.
FDA Approves Yusimry, the Seventh Adalimumab Biosimilar
Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.
AbbVie Returns to Court in Effort to Block Alvotech Adalimumab Biosimilar Candidate
After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.
Panelists Discuss Regulatory Perspective on Biosimilars
A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.
Molecular Selection Boosts pCR Rate in Early Breast Cancer Trial
Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.
SB12 Eculizumab Biosimilar Candidate Demonstrates PK, PD Equivalence in Phase 1 Trial
In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.
Alvotech Gains EC Approval for Adalimumab Biosimilar
Alvotech has received European Commission (EC) approval to begin marketing its adalimumab biosimliar AVT02, the company announced this week.
Study: Data for Cross-Switching of Biosimilars Are Scarce but Supportive
Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products.
Xbrane Seeks to Bring Keytruda and Darzalex Biosimilars to Market
Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.
Biosimilar-Gedatolisib Combo Elicits Response in Resistant mBC
In metastatic breast cancer (mBC) resistant to multiple lines, Herzuma (a trastuzumab biosimilar) plus gedatolisib, an mTOR/PI3K signaling pathway inhibitor, demonstrated value.
Patient-Provider Surveys Elucidate Biosimilar Switching Process in Oncology
After a switch to a biosimilar, patients and their oncologists may not always agree on how well the switch was described or whether the patient felt involved.
Ontruzant Biosimilar Demonstrates Equivalence to Herceptin in 5-Year Study
The trial included "drifted" (nonstandard) reference product, forcing a stratified analysis to yield relevant data.
Alvotech Lines Up Capital for a Biosimilars IPO
Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).
EirGenix Trastuzumab Biosimilar Candidate Demonstrates Equivalence in HER2-Positive Breast Cancer
A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.
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