Western European markets for biosimilar and generic drugs: worth differentiating

Garattini, Livio; Curto, Alessandro; Vooren, Katelijne van de

doi:10.1007/s10198-015-0684-y

Cited by 7 publications

(3 citation statements)

References 18 publications

(24 reference statements)

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“…The Fc region of infliximab is human, while the Fv region with the complementarity determining region (CDR) that binds human tumor necrosis factor alpha (TNF) is derived from the mouse. Infliximab binds soluble and transmembrane human TNF and blocks its interaction with p55 and p75 cell surface TNF receptors, thereby neutralizing the proinflammatory effects of TNF [6]. A number of nonclinical in vivo studies were conducted during the development of infliximab.…”

Section: Introductionmentioning

confidence: 99%

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)

et al. 2016

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IntroductionPF-06438179, a potential biosimilar to Remicade® (infliximab, Janssen Biotech, Inc.), is a chimeric mouse–human monoclonal antibody targeting human tumor necrosis factor alpha (TNF).MethodsAnalytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU).ResultsThe peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences. Data on post-translational modifications, biochemical properties, and biological function provided strong support for analytical similarity. Administration of a single intravenous (IV) dose (10 or 50 mg/kg) of PF-06438179 or infliximab-EU to male rats was well tolerated. There were no test article-related clinical signs or effects on body weight or food consumption. Systemic exposures [maximum drug concentration (C max) and area under the concentration–time curve (AUC)] in rats administered PF-06438179 or infliximab-EU were similar, with mean exposure ratio of PF-06438179 relative to infliximab-EU ranging from 0.88 to 1.16. No rats developed anti-drug antibodies. A 2-week IV toxicity study was conducted with once-weekly administration of 10 or 50 mg/kg of PF-06438179 to male and female rats. PF-06438179-related hyperplasia of sinusoidal cells occurred in the liver in rats administered 50 mg/kg, but was not adverse based on its minimal to mild severity. The no-observed adverse-effect level for PF-06438179 was 50 mg/kg. At this dose, C max was 1360 µg/mL and AUC at 168 h was 115,000 µg h/mL on day 8.ConclusionsThe analytical and nonclinical studies have supported advancement of PF-06438179 into global comparative clinical trials.FundingPfizer Inc.

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Section: Introductionmentioning

confidence: 99%

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)

et al. 2016

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“…Technical and recruitment issues for such trials are to be expected [37][38][39] which regulators possibly failed to anticipate. The incentive for patients to participate in clinical trials is typically the expectation that the investigational treatment could potentially be better than the standard -if not for the participating individual, then for future patients.…”

Section: What Is the Expected Benefit Of Biosimilars?mentioning

confidence: 97%

Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

Schulz

Bönig

2016

Current Opinion in Hematology

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“…For the others, answers indicated that prohibition of pharmacylevel substitution is notably linked to the absence of reference Literature suggests that biosimilar competition is likely to differ from small-molecule generic drug competition: besides the entry hurdles -more intense research and development investment, higher manufacturing costs -Mestre-Ferrandiz et al point to concerns among some physicians requiring more intense education, and concludes that, '… we can expect fewer biosimilar entrants and consequently less intense biosimilar price competition', [12]. However, other articles also suggest that the intensity of the price competition could be stronger, notably based on the price decreases observed for some biosimilars already marketed for several years in Europe [13].…”

Section: Substitutionmentioning

confidence: 99%

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Reiland¹,

Freischem²,

Roediger³

2017

GaBI J

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Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the fi rst biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off -patent biologicals. Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas. Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specifi c policies for off -patent biologicals in place and therefore take account of the specifi cities of biologicals. Nevertheless, variations exist and refl ect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the fi rst EBE survey, shifts have been seen in the areas of substitution and interchangeability. Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place that refl ect the diff erent nature of biological medicines. However, policies and their implementation vary among diff erent jurisdictions.

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Western European markets for biosimilar and generic drugs: worth differentiating

Cited by 7 publications

References 18 publications

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)

Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to Remicade® (Infliximab)

Update on biosimilars of granulocyte colony-stimulating factor – when no news is good news

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

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