Phase 1 Study Demonstrates Bioequivalence Between Enoxaparin Biosimilar vs Reference Product
September 10th 2022A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.
Getting Rid of Clinical Efficacy Testing for Biosimilars Is Needed, Ethical
September 8th 2022In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.
Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options
September 6th 2022In the first article of a 4-part series, The Center for Biosimilars® offers specifics for each of the adalimumab biosimilar products coming in 2023 and explains why the experience in Europe may differ from what’s coming in the United States.
Alvotech Brings in $40 Million in Revenue for First Half of 2022
September 5th 2022Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.
Biosimilars Regulatory Roundup for August 2022—Podcast Edition
September 4th 2022On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.
Vizient Survey Reveals Provider Motivations for Choosing Biosimilar Over Humira
August 23rd 2022Vizient’s 2022 Biosimilar Survey found that health care organizations consider interchangeable designations to be very important in prescription decision-making, signaling the interchangeability could play a big role in the adoption of adalimumab biosimilars.
FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar
August 17th 2022The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.
Study: Biosimilar Uptake, Rather Than Competition, Will Influence Price Decreases
August 15th 2022Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.
Not So Different: Biosimilars Oncology Roundup for July 2022—Podcast Edition
August 7th 2022On this episode of Not So Different, we recap some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar.
Vizient Market Outlook Report Predicts Trends for Adalimumab Biosimilars in 2023
August 2nd 2022Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.
Organon's Jim Carey Shares Thoughts on Biosimilar Legislation, Emerging Adalimumab Products
July 31st 2022Jim Carey, head of US policy and government relations at Organon, a spinoff company from Merck, breaks down strategies to push forward biosimilar legislation, the anticipation for adalimumab biosimilars, and more in this multi-part interview.
Companies Clinch Deals for Global Biosimilar Commercialization
July 26th 2022Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.