November 25th 2023
A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
BioRationality—A Dr. Sarfaraz Niazi Column: Lessons From 2022 Biosimilar Events
January 4th 2023Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.
Biocon’s Biosimilar Insulin Demonstrates PK, PD Equivalence to Humulin
December 3rd 2022The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found PK and PD equivalence between the biosimilar insulin-70/30 and Humulin-70/30.
VOLTAIRE-X Findings in Patients With Chronic Plaque Psoriasis Supported Interchangeability
November 26th 2022The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).
A Summary of the VOLTAIRE-RA Trial for Physicians, Patients Considering RA Treatment Options
November 5th 2022Authors of a plain-language summary of the VOLTAIRE-RA study examined how to help patients with rheumatoid arthritis (RA), their families, patient advocates, and health care professionals learn about potential new treatment options as the United States prepares for the introduction of adalimumab biosimilars.
AAM Report: Biosimilars, Generics Generated Billions of Dollars in Savings in 2021
November 1st 2022Biosimilar and generic drugs accumulated $373 billion in savings in 2021, $7 billion of which can be attributed to biosimilars alone, according to a report from the Association for Accessible Medicines (AAM).
Overview of Trastuzumab Biosimilars in HER2-Positive Breast Cancer
October 29th 2022Authors of a systematic review summarized the results of 21 published studies on the efficacy, safety, and cost-benefit ratio of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years
October 19th 2022Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.
Contributor: The Biosimilars Wave Is Crashing on the Shores of Biopharma Development
October 17th 2022St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.
Trastuzumab Biosimilar Found Safe, Effective in Pretreated HER2-Positive Breast Cancer
October 15th 2022A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
A Guide to Biosimilars for Retinal Diseases
September 24th 2022In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.
Biosimilar Insulin Lispro Shows Similar PK and PD Parameters to Humalog
September 17th 2022A phase 1 study in Japan found similar pharmacokinetic (PK) and glucose pharmacodynamic (PD) parameters between the biosimilar SAR342434 (SAR-Lis, Sanofi) and the Japan-reference insulin lispro (Humalog) in healthy male participants.
Eye on Pharma: Good News, Bad News for Alvotech; EpiVax Secures FDA Grant for Biosimilar Testing
September 12th 2022As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.
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.
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.
Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development
September 3rd 2022In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.
Dr Ivo Abraham Column: It's What We Do With the Savings—Economics and Equity
August 30th 2022Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.
Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points
August 24th 2022Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.