Cell line access to revolutionize the biosimilars market.
Ontology highlight
ABSTRACT:
SUBMITTER: Gotham D
PROVIDER: S-EPMC6051195 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
Publications
Biologic drugs are notoriously expensive. Biosimilars, though priced lower, are also costly. Analysis of the cost of production of biologics suggests that the cost of manufacture is in many cases less than 10% of the price in high-income countries, and less than a third of the price of biosimilars in India. This in turn implies that the relatively high prices of biosimilars are largely due to the need to undertake laborious reverse-engineering and phase 3 trials to demonstrate clinical similarit ...[more]
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Project description:As the patents associated with the biologics are set to expire in the near future, a new type of therapy appears on the horizon, and it is quite similar to the biologics. This commentary examines the biomedical and market issues surrounding the advent of biosimilars.
| S-EPMC4972733 | biostudies-other
Project description:Introduction and objectiveCell therapies can be classified into three main categories of products: advanced therapy medicinal products (ATMPs), ATMPs prepared on a non-routine basis (hospital exemptions), and minimally manipulated cells. Despite the benefits that cell therapies can bring to patients, they are subject to complex pathways to reach the market in France. The objective of this study was to identify and describe routes to market access for cell therapies in France and how these vary by regulatory status.MethodologyThe research was structured following five main steps: (1) identification of the French regulatory framework for cell therapies; (2) identification of the health products categorised as cell therapies in France; (3) mapping of the market access pathways per category of cell therapy; (4) validation of findings by interviewing experts; and (5) development of a roadmap summarising market access pathways for cell therapies in France. The secondary research methodology included a comprehensive literature review conducted on websites of French public health institutions, complemented by a research for peer-reviewed articles, abstracts, and grey literature.ResultsDifferent market access pathways are possible depending on the cell therapy category. For ATMPs, market access pathways depend on the licensing status of the therapy. Licensed ATMPs followed the same market access pathways as 'conventional' pharmaceuticals, whereas not-yet-licensed ATMPs can be funded via a specific financial allowance under the framework of a Temporary Authorisation for Use procedure or various research programmes. For new ATMPs that are associated with a separate medical device (not considered as 'combined ATMPs') or associated with a new medical procedure, additional pathways will apply for the medical device and/or medical procedure to be reimbursed in the ambulatory settings or at hospital. The most likely funding option for ATMPs prepared on a non-routine basis is outside the diagnosis-related group (DRG) system through Missions of General Interest and Support to Contracting (MIGAC). For minimally manipulated cells, four different funding processes are applicable, depending on the type of activity: (1) inclusion in a DRG; (2) inclusion in the list of products and services qualifying for reimbursement (LPPR) (as a medical device); (3) an annual lump sum provided by regional health agencies; and (4) a financial allowance under Missions of General Interest (MIG).ConclusionCell therapy is a diverse and promising category of medical interventions. Its heterogeneity and complexity mean that several funding options and market access pathways apply. The main challenges facing cell therapies relate to (1) the identification of the most appropriate path to reimbursement, and (2) price setting, whereas high manufacturing costs of these therapies will dictate a high price that could only be achieved by a product that leads to important additional patient benefits compared to available treatment options. More specific funding options could emerge as the number of cell therapies increases and the authorities face the need to structure and stabilise funding. It will be vital for manufacturers to have a clear understanding of the various temporary funding opportunities early in a product's lifecycle for the adoption of a stepwise approach to secure permanent funding. Furthermore, due to the very limited Health Technology Assessment (HTA) bodies experience for cell therapies, manufacturers should enter into dialogues with HTA agencies at an early stage to optimise market access conditions.
| S-EPMC4802688 | biostudies-literature
Project description:BackgroundDrug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.ObjectiveThis study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.MethodsThe case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses.ResultsA total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05).ConclusionWe found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change of administration from ambulatory to hospital setting seemed to be significantly correlated with a price increase for the target product, only one case was retrieved for this parameter; as such, it was not possible to infer a firm correlation between this parameter and a change in price.
| S-EPMC4865758 | biostudies-literature
Project description:Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply. The cost of biologics limits accessibility of cancer treatment for many patients. Effective and affordable cancer therapies are needed globally, more so in developing countries, where health care resources can be limited. Biosimilars, which have biologic activity comparable to their corresponding reference drugs and are often more cost effective, have the potential to enhance treatment accessibility for patients and provide alternatives for decision makers (ie, prescribers, regulators, payers, policymakers, and drug developers). Impending patent expirations of several oncology biologics have opened up a vista for the development of corresponding biosimilars. Several countries have implemented abbreviated pathways for approval of biosimilars; however, challenges to their effective use persist. Some of these include designing appropriate clinical trials for assessing biosimilarity, extrapolation of indications, immunogenicity, interchangeability with the reference drug, lack of awareness and possibly acceptance among health care providers, and potential political barriers. In this review, we discuss the potential role and impact of biosimilars in oncology and the challenges related to their adoption and use. We also review the safety and efficacy of some of the widely used biosimilars in oncology and other therapeutic areas (eg, bevacizumab, darbepoetin, filgrastim, rituximab, and trastuzumab).
| S-EPMC5646904 | biostudies-literature
Project description:Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries. On average nine to twelve times more patents were asserted against biosimilars in the United States than in Canada and the United Kingdom. Biosimilars also enter the Canadian and UK markets more quickly than they do in the United States following regulatory approval. Later market entry is not a problem when the brand name drug company is asserting high quality patents (i.e. patents covering significant advances). Consequently, we drilled down into the U.S. patent portfolio of one major biologic, Abbvie's Humira drug, and found that it was made up of roughly 80% non-patentably distinct (duplicative) patents linked together by terminal disclaimers, which is permitted under United States Patent and Trademark Office (USPTO) rules. In contrast, there were far less non-duplicative European patents that covered Humira. Patent thickets can allow brand name drug companies to delay biosimilar entry by relying on the high cost of challenging many duplicative patents instead of the quality of their underlying patents. Accordingly, we suggest several policy interventions that may thin these biologic patent thickets.
| S-EPMC9439849 | biostudies-literature
Project description:BackgroundBiological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases. Biosimilars, clinically equivalent to biological originator products, are expected to restrain drug costs in the biological market.ObjectiveThis study aimed to examine the impact of the biosimilar market entry on the prices of the reference products in outpatient care in Finland, investigate the impact of biosimilar market entries on price competition among biological medicinal products, and examine how the prices and market shares of outpatient biosimilars have developed in Finland during 2009-2020.MethodsThis retrospective register study applied data from IQVIA covering national community pharmacy wholesale data between 1 January, 2009, and 31 August, 2020, for somatropin, epoetin, filgrastim, follitropin, insulin glargine, insulin lispro, etanercept, pegfilgrastim, adalimumab, teriparatide, and enoxaparin biosimilars and their reference products, in addition to two relevant insulin products. We determined the monthly wholesale amounts in defined daily doses and wholesale weighted average prices (excluding value-added tax) per defined daily dose for each product. We analyzed the evolution of the price and market shares. We performed a linear segmented regression analysis to examine the impact of the market entry of biosimilars on the prices of reference products.ResultsThe prices of the reference products mainly decreased after the biosimilar entered the market. If the reference product price was not reduced, it was no longer reimbursable after evaluation under the Health Insurance Act, leading to marginal market shares. The changes in the prices of biosimilars were not as remarkable as the changes in the prices of reference products after the biosimilar market entry. For most active substances, biosimilar prices were stable or decreased. The utilization of biosimilars varied widely between different active substances at the end of the observation period.ConclusionsChanges in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future.
| S-EPMC9271098 | biostudies-literature
Project description:Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. However, due to their high costs, considerable differences in their utilization exist across the world, even among the various European countries, with many countries restricting access despite professional society guideline recommendations. Adoption of biologics by healthcare providers has been particularly poor in many Central and Eastern European countries. Differences in utilization have also been observed across medical specialties, healthcare providers, and at a regional and national level. The objective of this paper is to provide an overview of the different market access policies for biologics in Europe and to investigate reasons for such differences. One of the potential solutions for providing broader access to IMID patients, where cost is the major barrier, is to encourage the use of biosimilars in place of their reference products. Biosimilars are generally less expensive alternatives to already licensed biological therapies and are approved on the basis that they are similar to the reference product in terms of quality, safety, and efficacy. Budget impact models predict considerable cost savings following the introduction of biosimilars in the next few years. These savings could be used to increase access to biologics and other innovative therapies.
| S-EPMC6447826 | biostudies-literature
Project description:OBJECTIVE:To explore whether Supplemental Nutrition Assistance Program-Education (SNAP-Ed) stakeholders (individuals involved in work to increase access to farmers' markets [FMs] for low-income populations) perceive the same barriers to shopping at FMs as those reported by SNAP participants in Washington State. DESIGN:Descriptive study; data included a stratified clustered random sample of SNAP participants and stakeholder interviews. SETTING:Washington State. PARTICIPANTS:A total of 400 SNAP participants and 51 SNAP-Ed stakeholders. MAIN OUTCOME MEASURES:The SNAP participants' reported barriers to accessing FMs and the SNAP-Ed stakeholders' perceptions of FM access barriers. ANALYSIS:Thematic content analysis, descriptive statistics, 2-sample tests of proportion, and Pearson chi-square tests (P < .025). RESULTS:A majority of SNAP participants reported they did not shop at an FM because it is inconvenient (n?=?193; 51%) and not financially viable (n?=?84; 22%). Moreover, 9% of SNAP participants (n?=?34) stated that they experienced no barriers. The SNAP-Ed stakeholders placed increased emphasis on transportation and cost barriers compared with the SNAP participants. CONCLUSIONS AND IMPLICATIONS:Comprehensive, multilevel strategies that reflect the perspectives of SNAP participants could increase SNAP use at FMs. Opening FMs in diverse locations at variable operating times may address convenience barriers while engaging the targeted populations' communities to promote FMs, and FM incentive programs may address financial and awareness barriers.
| S-EPMC7416758 | biostudies-literature
Project description:ObjectiveThe association between farm production diversity and dietary diversity in rural smallholder households was recently analysed. Most existing studies build on household-level dietary diversity indicators calculated from 7d food consumption recalls. Herein, this association is revisited with individual-level 24 h recall data. The robustness of the results is tested by comparing household- and individual-level estimates. The role of other factors that may influence dietary diversity, such as market access and agricultural technology, is also analysed.DesignA survey of smallholder farm households was carried out in Malawi in 2014. Dietary diversity scores are calculated from 24 h recall data. Production diversity scores are calculated from farm production data covering a period of 12 months. Individual- and household-level regression models are developed and estimated.SettingData were collected in sixteen districts of central and southern Malawi.SubjectsSmallholder farm households (n 408), young children (n 519) and mothers (n 408).ResultsFarm production diversity is positively associated with dietary diversity. However, the estimated effects are small. Access to markets for buying food and selling farm produce and use of chemical fertilizers are shown to be more important for dietary diversity than diverse farm production. Results with household- and individual-level dietary data are very similar.ConclusionsFurther increasing production diversity may not be the most effective strategy to improve diets in smallholder farm households. Improving access to markets, productivity-enhancing inputs and technologies seems to be more promising.
| S-EPMC5244442 | biostudies-literature
Project description:Electrochemical systems function via interconversion of electric charge and chemical species and represent promising technologies for our cleaner, more sustainable future. However, their development time is fundamentally limited by our ability to identify new materials and understand their electrochemical response. To shorten this time frame, we need to switch from the trial-and-error approach of finding useful materials to a more selective process by leveraging model predictions. Machine learning (ML) offers data-driven predictions and can be helpful. Herein we ask if ML can revolutionize the development cycle from decades to a few years. We outline the necessary characteristics of such ML implementations. Instead of enumerating various ML algorithms, we discuss scientific questions about the electrochemical systems to which ML can contribute.
| S-EPMC8042659 | biostudies-literature