A Plain Language Summary Describing how Two Different Concentrations of GP2017, a Biosimilar Adalimumab Medicine, are Associated with Similar Drug Levels within the Body

Plain Language Summary

This plain language summary explains, in simple terms, the results of a study from 2022 discussing a biosimilar medicine called GP2017 (called SDZ-ADL in this summary, sold as Hyrimoz^®). This medicine is used to treat people with inflammatory conditions. This study investigated a new, high-concentration formulation of GP2017 (SDZ-ADL-HCF) in order to show that the high concentration option acts the same way in the body as SDZ-ADL. SDZ-ADL-HCF has been submitted for regulatory approval to health authorities on the basis of this study and was recently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for people with the inflammatory conditions that SDZ-ADL is used to treat. This newly developed formulation provides the option for receiving injections less often with reduced volumes which can have a positive impact on the injection experience and increase patient convenience.

What was the aim of the current study?

This study looked at the pharmacokinetics of SDZ-ADL and SDZ-ADL-HCF, meaning it compared how the active medicine behaved in the body at different times after the injection of each of the formulations. The study also looked at how each formulation was recognized by the body’s immune system (known as immunogenicity), and the side effects associated with each formulation. This study was randomly assigned and double-blinded, meaning that neither the participants nor the researchers knew which formulation each participant received. This reduces the risk of bias in the results.

What were the findings from the current study?

The study found that an injection of SDZ-ADL-HCF resulted in similar amounts of the medicine being present within the blood as an injection of SDZ-ADL. This information was needed for the approval of SDZ-ADL-HCF. Participants also experienced similar immune reactions and the number of participants with side effects was similar between both concentrations of medicine. The results confirmed that SDZ-ADL-HCF behaves in the same way in the body and is expected to have the same treatment effects as SDZ-ADL, while at the same time offering an improved formulation with a more positive injection experience and increased patient convenience.

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Keywords::

• antibody therapeutics
• arthritis
• autoimmunity
• dermatology
• immunological disorders
• immunotherapy
• inflammatory bowel disease

This article is related to:

GP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar

Acknowledgments

Sandoz would like to thank all study participants that took part in this trial.

Financial disclosure

This study was sponsored by Hexal AG/Sandoz. AB has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. NG has acted as a clinical study investigator (institution has received clinical study funds) for Sandoz. PW has served as a speaker (received honoraria) for AbbVie, Astra Zeneca, Eli Lilly, Medac, MSD, Novartis, Sandoz, and served as a scientific adviser (received honoraria) for Pierre Fabre and Pfizer, and has acted as an investigator in clinical studies for: Biothera, BMS, Easthorn, Eli Lilly, Janssen, Novartis, Parexel, and UCB. RC has served as a speaker (received honoraria) for AbbVie, Takeda, BMS/Celgene, served as a scientific adviser (received honoraria) for AbbVie Laboratories, BMS/Celgene, Eli Lilly, Genentech, Gilead Sciences, Hoffmann La-Roche, Janssen, Pfizer, Takeda, UCB Pharma, served on a data safety board for Reistone Biopharma, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, BMS/Celgene, Boehringer Ingelheim, Crohn’s & Colitis Foundation of America, Genentech, Gilead Sciences, Hollister, Medimmune, Mesoblast Ltd., Osiris Therapeutics, Pfizer, Receptos, RedHill Biopharma, Sanofi-Aventis, Schwarz Pharma, Seres Therapeutics, Takeda Pharma, and UCB Pharma. SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, J&J, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor, and payment for expert testimony from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

CB, SJ, CF, LL are employees of Sandoz. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

Writing disclosure Medical writing support for this summary was provided by Syneos Health and was funded by Hexal AG (a Sandoz company).

Ethical disclosure

The study was conducted in accordance with the ICH E6 Guideline for Good Clinical Practice, and with the ethical principles outlined in the Declaration of Helsinki. All subjects provided written informed consent. The study protocols were approved by the Institutional Review Board (Advarra, 6940 Columbia Gateway Dr. Suite 110, Columbia, MD, USA).

Additional information

Funding

This study was sponsored by Hexal AG/Sandoz. AB has served as a speaker (received honoraria) for AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Regeneron, and Sanofi, served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly and Company, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB Pharma, Union, Ventyx, Vibliome, and Xencor, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Concert, Dermavant, Eli Lilly and Company, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB Pharma, and Ventyx. NG has acted as a clinical study investigator (institution has received clinical study funds) for Sandoz. PW has served as a speaker (received honoraria) for AbbVie, Astra Zeneca, Eli Lilly, Medac, MSD, Novartis, Sandoz, and served as a scientific adviser (received honoraria) for Pierre Fabre and Pfizer, and has acted as an investigator in clinical studies for: Biothera, BMS, Easthorn, Eli Lilly, Janssen, Novartis, Parexel, and UCB. RC has served as a speaker (received honoraria) for AbbVie, Takeda, BMS/Celgene, served as a scientific adviser (received honoraria) for AbbVie Laboratories, BMS/Celgene, Eli Lilly, Genentech, Gilead Sciences, Hoffmann La-Roche, Janssen, Pfizer, Takeda, UCB Pharma, served on a data safety board for Reistone Biopharma, and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, BMS/Celgene, Boehringer Ingelheim, Crohn’s & Colitis Foundation of America, Genentech, Gilead Sciences, Hollister, Medimmune, Mesoblast Ltd., Osiris Therapeutics, Pfizer, Receptos, RedHill Biopharma, Sanofi-Aventis, Schwarz Pharma, Seres Therapeutics, Takeda Pharma, and UCB Pharma. SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, J&J, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB, and Vifor, and payment for expert testimony from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.