Biologics: Targets and Therapy

Biologics: Targets and Therapy is pleased to invite you to the upcoming Article Collection “Biosimilars, Biobetters, and Bioparallels” led by Professor Ivo Abraham, Ms. Ansam Beddor, Dr. Nimer Alkhatib, and Dr. Karen MacDonald.

Looking back on almost three decades of biosimilars and despite their difficult start in Europe in 2015, biosimilars are solidly embedded in patient care and have become a mainstay in human therapeutics – at least in high income countries. Being equivalent in efficacy/effectiveness, safety and (mainly) priced lower than the originators they reference, biosimilars enable savings, expanded patient access, and greater patient equity.

Furthermore, two recent developments have broadened the “later-in-class” biologics space beyond biosimilars. In October 2023, the United States Food and Drug Administration (FDA) approved Zymfentra, a subcutaneous (SC) formulation of Inflectra, an intravenous (IV) biosimilar referencing infliximab (Remicade). Rather peculiar but this SC formulation is approved in other jurisdictions as a biosimilar – along with its IV formulation – but in the US as a biological. Zymfentra is increasingly being referred to as a biobetter, in this case of a biosimilar (Inflectra) of originator infliximab (Remicade). Additional biobetters are on the horizon – as novel agents of biosimilar candidates that failed the upper bound of the equivalence margin.

That same month, the FDA also approved toripalimab (Loqtorzi), the first Chinese PD-1 inhibitor based exclusively on Chinese clinical trials: not a biosimilar and neither a biobetter, but a bioparallel. It is a new biological molecule without the ambition of being an early-in-class innovator but instead a “later-in-class” entry, analogous (but not similar) in efficacy and safety, competing on price. There are more are on the horizon as well.

While there can be clear benefits for adopting biosimilars, biobetters and bioparallels, many issues remain to be addressed: regulatory pathways; clinical evidence in support of regulatory approval; interchangeability; pricing and competition; commoditization of biological therapy; and the need for global access, especially in low, lower-middle and higher-middle income countries – among many others.

To help address these issues, Biologics: Targets and Therapy invites authors to submit Original Research, Reviews, and Commentaries on relating to biosimilars, biobetters and bioparallels. Potential topics include but are not limited to:

• Clinical studies into the use of biosimilars, biobetters and bioparallels
• Bioequivalence studies
• Pharmacoeconomic analyses
• Research relating to the regulation, pricing, re-imbursement and market uptake of biosimilars, biobetters and bioparallels

Keywords: Biosimilars, Biobetters, Bioparallels

Please review the Submission Instructions below prior to submitting an abstract and/or manuscript.

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Article Collection Guest Advisors

Ivo Abraham is a Professor in the Department of Pharmacy Practice and Science, R. Ken Coit College of Pharmacy, with joint appointments in the Department of Family and Community Medicine and the Department of Clinical Translational Sciences. He has also served on the faculty of Case Western Reserve University, University of Virginia, and (part-time) KU Leuven (Belgium); and as a visiting professor at universities in the US, Europe, and Asia.

Having been a member of several editorial boards, he currently serves as the Quantitative Methods Editor of JAMA Dermatology and as Editor-in-Chief of the Journal of Medical Economics. In the US, he has served as a chartered or ad hoc study section member for the NIH, NIMH, AHRQ, VA, and NSF since 1985. He has served as an expert adviser to the Innovative Medicines and Innovative Health Initiatives, a joint 7.4 billion euro undertaking of the European Union and the industry to stimulate research and innovation in human therapeutics, vaccines, as well as diagnostics and other technologies, from their inception in 2008. He has also served as an expert to various public and private funding agencies in European, Asian, and North American countries.

Ansam Beddor completed her BS in Pharmacy at Jordan University of Science and Technology in 2022. Being the first in her class of over 600 students, she received a 4-year fellowship from her university to pursue a PhD at the University of Arizona. She started her PhD studies in the Fall of 2023 and is focusing on the clinico-economic value of human therapeutics.

Nimer Alkhatib has over 12 years of work experience in various health care sectors worldwide. In 2011, Nimer completed his PharmD degree from the Jordan University of Science and Technology in Jordan. During his studies, he served in World Health Organization (W.H.O) and as a regional projects officer for the International Pharmaceutical Students’ Federation (IPSF). Following graduation, he worked in community pharmacies and the pharmaceutical industry in the Middle East region. In 2015, Nimer received a full scholarship for graduate studies from the Center of Health Outcomes and PharmacoEconomic Research (HOPE Center) at the University of Arizona, USA; completing his MS in 2017 and PhD in 2019, focusing on the value of health care and methods for value-based pricing. He was appointed to the Faculty of Pharmacy at Al-Zaytoonah University in 2019. Since 2015, Nimer has served as a health economic analyst and consultant for various health care agencies and pharmaceutical industry in the USA, Europe, and the MENA region.

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Conflicts of Interest

Ivo Abraham holds equity in Matrix45, LLC, which provides scientific and consulting services to biopharmaceutical, diagnostics, and medical device companies on a non-exclusivity basis; government and international agencies; and academic or health care institutions. By company policy, owners and employees are prohibited from holding equity in client and sponsor organizations (except through mutual funds or other independently administered collective investment instruments), contracting independently with client and sponsor organizations, or receiving compensation independently from such organizations. Any compensation related to the provision of services to government and international agencies, academic institutions, and healthcare institutions by equity owners is collected by Matrix45. Matrix45 provides its services on a non-exclusivity basis.

Matrix45, LLC and predecessor companies in which Ivo Abraham holds or has held equity, have been contracted for research, analytics, dissemination, consulting, and training services by Janssen/Johnson & Johnson, Amgen, Novartis, and Roche on the originator side; and by Sandoz/Novartis, Coherus Biosciences, CellTrion, Mylan/Viatris/Biocon, Hospira/Pfizer, Teva, and Eastern Research Group on the biosimilars side; with past and current conversations with Merck KGaA, Apobiologix, Apogenix, and Fresenius-Kabi.

Ivo Abraham is the Quantitative Methods Editor of JAMA Dermatology, which is a compensated editorship contracted to Matrix45. He is Deputy Editor-in-Chief of the Journal of Medical Economics, which is an uncompensated editorship but for which he receives an allotment of submissions free of publication charges.

Manuscript Submissions:

All manuscripts submitted to this Article Collection will undergo desk assessment and a full peer-review. Please review the journal scope and author submission instructions prior to submitting a manuscript as it will be rejected if it does not fall within the scope of the journal.

The deadline for submitting manuscripts is 31st January 2025. 

Please submit your manuscript on our website, quoting the promo code ENTUK to indicate that your submission is for consideration in this Article Collection. Please include any discount codes before you submit as these will not be applied retrospectively.

Please contact Ashley Ambros with any queries and discount codes regarding this Article Collection.

Instructions for AuthorsSubmit an Article