Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD
September 19th 2023A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.
Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing
September 18th 2023Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development
September 13th 2023An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
AAM Report: Generics and Biosimilars Generate $408 Billion in 2022
September 12th 2023A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.
Fran Gregory Weighs In on the Value of Interchangeability in the Adalimumab Market
September 10th 2023Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.
Regulatory Updates From Around the Globe Provide Hope for Biosimilars
September 9th 2023An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
Stelara and Enbrel Chosen for IRA Price Negotiation
August 29th 2023Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).
Cardinal Health's Dr Fran Gregory Reacts to First MS Biosimilar Approval
August 27th 2023Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).
Meta-Analysis Confirms Clinical Equivalence Between RA Biosimilars, Originators
August 26th 2023A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab biosimilars were clinically equivalent to their reference products.
Cardinal Health Exec: How Adalimumab Biosimilars Can Reshape the US Health Care Industry
August 23rd 2023Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, published her opinions on the future of biosimilars in the United States, foreshadowing immense growth and a transformation of the US health care industry thanks to biosimilars.
How Streamlining Development Can Save the US Biosimilar Industry
August 20th 2023On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.
Spanish Psoriasis Working Group Revises Guidelines for Biosimilars in Psoriasis
August 10th 2023The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.
Sintilimab Plus Bevacizumab Biosimilar vs Avastin Is Cost-Effective in HCC
August 8th 2023A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.
Despite Global Increase in Amjevita Sales, US Sales Dropped 63%
August 5th 2023Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.
Eye on Pharma: Interchangeability Study Results; Express Scripts to Cover Cyltezo; TDM for Idacio
August 3rd 2023Samsung Bioepis and Organon released results from an interchangeability study of its adalimumab biosimilar; Express Scripts announced that it will add Cyltezo as well as 2 other adalimumab biosimilars to its formulary list; Anser Therapeutics will offer therapeutic drug monitoring (TDM) for Idacio.
Abstracts Highlight Growing Comfortability With Trastuzumab Biosimilars in Breast Cancer
July 31st 2023Abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO 2023) emphasized the safety and efficacy of a trastuzumab biosimilar in treating HER2-positive breast cancer and growing utilization of trastuzumab biosimilars over time.
Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed Explains
July 30th 2023Why are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.
Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen
July 26th 2023Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.
AAM White Paper Breaks Down Drug Shortage Crisis: Causes and Solutions
July 25th 2023The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.