Emerging Insights into European Markets of Biologics, Including Biosimilars

Simoens, Steven; Huys, Isabelle

doi:10.3390/ph15050615

Cited by 2 publications

(2 citation statements)

References 11 publications

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“…MA holder Biogen says it bases its pricing on "clinical benefit" and the "prices of other orphan drugs". 185 However, the civil society groups object that Biogen invested US$648 million in the development of the medicine. 186 If this is correct, then (based on the aforementioned average worldwide price per patient per year) Biogen would have recouped its direct R&D costs after treating 3,564 patients in one year.…”

Section: Excessive Pricing Of a Patent-protected Medicine?mentioning

confidence: 99%

Excessive Pricing in Pharmaceuticals under Article 102 TFEU

Veraldi

2023

Eur. j. risk regul.

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High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.

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Section: Excessive Pricing Of a Patent-protected Medicine?mentioning

confidence: 99%

Excessive Pricing in Pharmaceuticals under Article 102 TFEU

Veraldi

2023

Eur. j. risk regul.

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“…A sustainable market refers to a situation in which both off-patent biological and biosimilar products can coexist. It therefore not only strives towards a competitive market, but also towards economic viability for pharmaceutical industry [ 11 ]. However, it has become clear that the Belgian market is not sustainable [ 12 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Determinants of prescribing decisions for off-patent biological medicines in Belgium: a qualitative study

Vandenplas¹,

Simoens²,

Wilder³

et al. 2022

BMC Health Serv Res

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Background A competitive market for off-patent biologicals leads to more affordable and high-quality healthcare. In recent years, Belgium has been characterized by its low use of biosimilars and by its shifts from off-patent biologicals toward new alternative therapies. Yet, the prescribing decisions involved in these observations are poorly understood. This study aims to better understand prescribing choices among Belgian physicians in the ambulatory care setting. Methods This study consisted of two phases. First, a scoping literature review to identify determinants of prescribing choices was conducted. Scientific databases (Embase and PubMed) were searched until 4 November 2021. Second, the nominal group technique (NGT) was employed during focus group discussions with Belgian physicians to consider and validate these determinants for off-patent biologicals in the Belgian context. The qualitative data resulting from the literature review and focus group discussions were analyzed using the thematic framework method. Results Fifty-three scientific articles that discussed elements that determine prescribing choices were identified. Out of these, 17 determinants of prescribing choices were found. These were divided into five categories: (1) product-related, (2) physicians’ personal, (3) healthcare system-related, (4) patient-related, and (5) determinants related to the pharmaceutical company or brand. Nineteen Belgian physicians from different therapeutic areas that regularly prescribe biologicals then participated in focus group discussions. Using the NGT, the group discussions revealed that prescribing choices for off-patent biologicals are determined by a complex set of elements. Clinical data, geographical region, working environment, pharmaceutical marketing, patient profile, clinical guidelines, and preference of key opinion leaders (KOL) were considered most influential. Physicians indicated that the importance of these determinants differs depending on product classes or therapeutic domain. Conclusions Multiple elements determine the choice of an off-patent biological or biosimilar product. The importance of each of these determinants varies depending on the context in which the prescribing choice is made. To increase the prescription of best-value biologicals in the Belgian ambulatory care, a set of synergistic measures is required including information for healthcare providers (HCP) and patients, prescribing feedback, prescribing targets, tangible incentives, KOL involvement, guidelines regarding pharmaceutical promotion, and regular revision of reimbursement modalities.

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Emerging Insights into European Markets of Biologics, Including Biosimilars

Abstract: Biological medicinal products have revolutionised the treatment of many diseases, e [...]

Cited by 2 publications

References 11 publications

Excessive Pricing in Pharmaceuticals under Article 102 TFEU

Excessive Pricing in Pharmaceuticals under Article 102 TFEU

Determinants of prescribing decisions for off-patent biological medicines in Belgium: a qualitative study

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