Tracking the price of existing biologics when drugs enter the market

Stiff, Katherine M; Cline, Abigail; Feldman, Steven R.

doi:10.1080/14737167.2019.1630274

Cited by 12 publications

(12 citation statements)

References 8 publications

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“…It should be noted, however, that the price reduction is not as significant as in the case of generic medicinal products based on chemical substances. Typically, the price of a biosimilar medicine is 65-85 percent of the reference medicine's price (Calo-Fernández & Martínez-Hurtado, 2012: 1393-1408Stiff, Cline & Feldman, 2019). The reason is higher costs of generation and registration than in the case of generic medicinal products based on chemical substances (Dolinar & Reilly, 2013: 36-40).…”

Section: Categories Of Biopharmaceuticalsmentioning

confidence: 99%

Biosimilars and the Patent Law

Świerczyński

Więckowski

2019

mls

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Biopharmaceuticals are one of the most important recent medical innovations which revolutionised many areas of medicine. Dynamic development of the market for biopharmaceuticals in recent years is related to the expiration of the IP exclusive rights on original innovative biological medicinal products. This has resulted in introduction to the market of biosimilars. One of the greatest challenges concerning the emergence of biosimilars is modifying the law to ensure balance between the market development of biosimilars and access of patients to biological therapy. The development of biopharmaceutical inventions works hand in hand with the patent system. It should be underlined that IP rights in the biopharmaceutical sector are crucial for promoting innovation due to the very long time of product development. It is exactly the area in which patents make sense to fill the gap between innovation and the risk of imitation. However, the existing patent system is too expensive and slow for biotechnology development. It should be further adapted to the needs of biopharmaceuticals.

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Section: Categories Of Biopharmaceuticalsmentioning

confidence: 99%

Biosimilars and the Patent Law

Świerczyński

Więckowski

2019

mls

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“…However, biologics pose an important challenge for the sustainability of healthcare systems worldwide, given the high direct costs associated with this drug category (1). For instance, expenses related to biologic treatments can represent almost 40% of the net drug spending in the United States (12).…”

Section: Introductionmentioning

confidence: 99%

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

Ascef

Almeida

Ribeiro

et al. 2020

Preprint

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Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence trials. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. Between-trial heterogeneity will be tested and quantified with the Q-test and I2 metric, respectively, whereas assessment of small-study bias will be examined through contour-enhanced funnel plots and Egger and Harbord's tests. Meta-regression models will be fitted when appropriate. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20) and the co-primary outcome will be the Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of evidence will be assessed based on the GRADE system.Discussion The two systematic reviews described here, to the best of our knowledge, are the first ones proposing a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. The results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic Review Registration Protocol synopses were previously registered on PROSPERO (CRD42019137152 and CRD42019137155).

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“…The term "biopharmaceutical" was fi rst used in the 1980s to describe therapeutic proteins obtained by biotechnological processes (Mehta 2019). Because of the patent expiry (Yamauchi, 2018) observed recently on numerous biological medicines (reference products), a competitive version called biosimilars (not generics) (Geigert, 2019) has started to share the market (Stiff et al, 2019). Even though they are not identical as generic version of chemically derived medicines, they are similar, which is refl ected in their safety and clinical features (Pawłowska et al 2019;Shah & Crommelin, 2019).…”

Section: Introductionmentioning

confidence: 99%

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

Więckowski¹

2019

EEJTR

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A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, fi rst of all towards the regranting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder).

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Tracking the price of existing biologics when drugs enter the market

Cited by 12 publications

References 8 publications

Biosimilars and the Patent Law

Biosimilars and the Patent Law

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for two systematic reviews and meta-analyses

Is the Compulsory Licensing Mechanism Guaranteed by TRIPS the Best Remedy to Improve Access to Biological Therapies Worldwide?

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