| 1. |
|
|
| 2. |
- Druedahl, Louise C., et al.
(författare)
-
Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
- 2021
-
Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361
-
Tidskriftsartikel (refereegranskat)abstract
- Background A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. Objective The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. Methods Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
|
|
| 3. |
- Druedahl, Louise C., et al.
(författare)
-
Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution
- 2022
-
Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:1
-
Tidskriftsartikel (refereegranskat)abstract
- Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
|
|
| 4. |
- Druedahl, Louise C, et al.
(författare)
-
Managing Complexity : Exploring Decision Making on Medication by Young Adults with ADHD.
- 2018
-
Ingår i: Pharmacy. - : MDPI AG. - 2226-4787. ; 6:2
-
Tidskriftsartikel (refereegranskat)abstract
- Attention-deficit hyperactivity disorder (ADHD) causes difficulties with hyperactivity, impulsivity and inattention. Treatment of ADHD includes both medication and non-pharmacological options. Knowledge of treatment preferences by young adults with ADHD is sparse. The objective of this study was to explore the beliefs and experiences of young adults with ADHD related to their medication treatment decisions. Data were collected in Denmark in 2016 through a focus group and individual in-depth interviews. Conventional content analysis was used. Ten young adults with ADHD (22-to 29-year-old) participated. Three major themes were identified: (1) the patient’s right to choose concerning ADHD medicine; (2) the patient’s decision of whether or not to treat ADHD with medication; and (3) factors affecting the patient’s decision on whether to take ADHD medication or not. The latter theme contained 15 factors, which were distributed across three levels: individual, between-individuals, and societal. The dominant factors were increasing quality of life and improving oneself e.g., improving social skills. For counselling at the pharmacy and by prescribers, it is important to be aware of the different factors that affect young adult patients’ decisions on whether to take ADHD medication or not. This knowledge will aid to understand reasons for non-adherence and to determine appropriate treatment for the individual patient.
|
|
