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Evolving Biosimilar...
Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
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- Druedahl, Louise C. (författare)
- Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Copenhagen Ctr Regulatory Sci CORS, Univ Pk 2, DK-2100 Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Social & Clin Pharm, Copenhagen, Denmark.;Univ Copenhagen, Fac Law, Ctr Adv Studies Biomed Innovat Law CeBIL, Copenhagen, Denmark.
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- Kälvemark Sporrong, Sofia (författare)
- Uppsala universitet,Institutionen för farmaci,Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Social & Clin Pharm, Copenhagen, Denmark.;Uppsala Univ, Fac Pharm, Dept Pharm, Social Pharm, Uppsala, Sweden.
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- van de Weert, Marco (författare)
- Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Drug Delivery & Biophys Biopharmaceut, Copenhagen, Denmark.
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- De Bruin, Marie Louise (författare)
- Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Copenhagen Ctr Regulatory Sci CORS, Univ Pk 2, DK-2100 Copenhagen, Denmark.;Univ Utrecht, Utrecht Inst Pharmaceut Sci, Utrecht, Netherlands.
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- Hoogland, Hans (författare)
- LEO Pharma AS, Ballerup, Denmark.
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- Minssen, Timo (författare)
- Univ Copenhagen, Fac Law, Ctr Adv Studies Biomed Innovat Law CeBIL, Copenhagen, Denmark.
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- Almarsdottir, Anna Birna (författare)
- Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Social & Clin Pharm, Copenhagen, Denmark.
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Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Copenhagen Ctr Regulatory Sci CORS, Univ Pk 2, DK-2100 Copenhagen, Denmark;Univ Copenhagen, Fac Hlth & Med Sci, Dept Pharm, Social & Clin Pharm, Copenhagen, Denmark.;Univ Copenhagen, Fac Law, Ctr Adv Studies Biomed Innovat Law CeBIL, Copenhagen, Denmark. Institutionen för farmaci (creator_code:org_t)
- 2021-04-08
- 2021
- Engelska.
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Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
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