Biologics: Targets and Therapy

Dove Medical Press 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 in Biologics: Targets and Therapy.

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

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.

The deadline for submitting manuscripts is 31st December 2025. Please note normal Article Processing Charges apply.

Please submit your manuscript on our website, quoting the promo code DJZNQ for a 10% discount on the Article Processing Charge and to indicate that your submission is for consideration in this Article Collection.

Please contact Ashley Ambros at [email protected] with any queries and discount codes regarding this Article Collection.

View all papers in this article collection

Dove Medical Press is pleased to invite you to the upcoming Article Collection “Regulatory (FDA) Critical Clinical Initiative in Drug Research and Development” in Biologics: Targets and Therapy.

In recent years, the United States (US) Food and Drug Administration (FDA) has kicked off a number of critical clinical initiatives to assist the sponsors in pharmaceutical research and development. These critical clinical initiatives include, but are not limited to, (i) biosimilar drug development, (ii) cancer research, (iii) adaptive trial design, (iv) real-world data (RWD) and real-world evidence (RWE), (v) model-informed drug development (MIDD), (vi) AI for mobile individualized medicine, (vii) rare disease drug development, (viii) biomarker development, (ix) precision and personalized medicine, and (x) benefit-risk assessment. The purpose of these critical clinical initiatives is not only to provide regulatory flexibilities in drug development, but also to improve, shorten or speed up the review and approval process of drug development. 

In the past decade, it is aware that increasing spending of biomedical research does not reflect an increase of the success rate of pharmaceutical development. Woodcock (2004) performed a diagnosis and found out the following problems (i) a diminished margin for improvement that escalates the level of difficulty in proving drug benefits. (ii) genomics and other new science have not yet reached their full potential, (iii) easy targets are the focus as chronic diseases are harder to study, (iv) failure rates have not improved, (v) rapidly escalating costs and complexity decrease willingness/ability to bring many candidates forward into the clinic. To fix the problems, FDA kicked off these critical clinical initiatives to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies. These critical clinical initiatives are important to provide the sponsors the flexibility for identifying any signal, possible trend/pattern, and ideally optimal benefit regarding safety/efficacy of the test treatment under investigation. In addition, these critical initiatives can help in speeding up the development process in a more efficient way without undermining the scientific validity of the development. 

Potential topics include but are not limited to:

• Biosimilar drug development
• Rare disease drug development
• Hybrid adaptive trial design
• Real-world data (RWD) and real-world-world evidence (RWE) or alternative and confirmatory data/evidence (ACD/ACE)
• Novel design and analysis for cancer research
• Model-informed drug development (MIDD)
• AI technology for biomarker development of imaging data
• Benefit- risk assessment

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.

The deadline for submitting manuscripts is 31st December 2025. Please note normal Article Processing Charges apply.

Please submit your manuscript on our website, quoting the promo code WZJNO for a 10% discount on the Article Processing Charge and to indicate that your submission is for consideration in this Article Collection.

Please contact Ashley Ambros at [email protected] with any queries and discount codes regarding this Article Collection.

 

View all papers in this article collection