(Press-News.org) Although conceptually they could be equivalent, a biosimilar drug is not a generic drug. The latter are exact copies of relatively simple molecules (paracetamol, acetylsalicylic acid), obtained by means of chemical synthesis methods. Biosimilars, by contrast, are copies of highly complex molecules of a protein nature, the production of which involves biological processes and materials, like cell culture or the extraction of products using living organisms, which is why there is no product that is exactly the same as the other. As they are comparable but not exact copies of the original drugs, the regulations governing generics is not scientifically appropriate for biosimilars. "Small variations in the molecule, even in the manufacturing process, could give rise to a slightly different product, and that is why their manufacture needs to be specifically regulated," stressed Begoña Calvo-Hernáez, Professor of Pharmacy at the UPV/EHU.
The studies in this field by the PharmaNanoGene group in the Pharmacy and Pharmaceutical Technology Area of the UPV/EHU's Faculty of Pharmacy began in 2006, and since then have prompted numerous publications, cited on many occasions in top journals, including the New England Journal of Medicine.
"Our research covers the studies that need to be done and are being demanded by the pharmaceutical industry for the development, approval and subsequent monitoring of biosimilar drugs in line with the regulations of the European Medicines Agency," explained Calvo. "On the basis of this, the health authorities will be able to set up a suitable regulatory environment, and the prescribing of these drugs, which are going to lead to significant savings for healthcare systems, can ultimately be increased," she added. These regulations, which are pioneering ones and a reference worldwide, were established in 2004; thanks to them, 12 biosimilar drugs have been approved in Europe, although in the United States none have been approved as yet.
Savings for the healthcare system
In percentage terms, the savings generated by biosimilars would not be as great as those generated by generics, which can lead to savings of as much as 40% per prescription. But because they are such expensive drugs —just one of these treatments can bring annual income in excess of 1,000 million euros for the laboratory— a small reduction in the cost of production is a great advantage for the system.
Among the biosimilars approved in Europe are the growth hormone erythropoietin (EPO), interferon and, more recently, the first biosimilars of monoclonal antibodies, specifically of Infliximab, designed to treat autoimmune diseases (rheumatological, psoriatic diseases and those linked to Crohn's, among others), and scheduled to be marketed from this year onwards. Monoclonal antibodies are molecules that are even more complex than the initial biosimilars, and they are expected to have a "huge" impact. It is reckoned that the introduction of biosimilar monoclonal antibodies could save over 20,000 million euros in Europe up until 2020.
According to forecasts of the IMS-Institute of Health Studies and Research, biosimilars could achieve a market share of 10% of biological drugs by 2020, with a volume of up to 25,000 million euros.
Calvo is in no doubt that we are facing a "key" moment in the development of biosimilars, "although their introduction will depend on how the health authorities want to promote them. In Spain the introduction of approved biosimilars varies: while some biosimilars have reached levels of introduction in the region of 50% (the case of filgrastim used among other purposes for combating the fall in defences in certain oncological patients treated with chemotherapy), others like erythropoietins are in the region of 20%, and the growth hormone around 5%.
INFORMATION:
Additional information
The pieces of research reported on in this press release have been carried out by members of the PharmaNanoGene group of the Area of Pharmacy and Pharmaceutical Technology of the UPV/EHU's Faculty of Pharmacy and have been led by the Professor of Pharmacy of the UPV/EHU Begoña Calvo-Hernáez. A total of 15 researchers are involved in this consolidated research group. The research into biosimilar drugs was started in 2006 with the PhD thesis of Leyre Zúñiga focussing on the analysis of the regulatory bases of approval of biosimilar drugs across Europe. Research has been continued since then in the same field. The publications resulting from the research (numerous papers in journals and book chapters as well as numerous papers at specialist conferences) have been cited on many occasions in papers published in leading journals. In particular, the following two papers have had a great impact:
B. Calvo, L. Zuñiga. "Therapeutic monoclonal antibodies: strategies and challenges for biosimilars development". Current Medicinal Chemistry 19: 4445-4450 (2012)
L. Zuñiga, B. Calvo. "Biosimilars: pharmacovigilance and risk management". Pharmacoepidemiology and Drug Safety 19: 661-669 (2010)
As a result of the research, activities to advise and train professionals in the pharmaceutical business internationally in the field of the development and approval of biosimilar drugs are being carried out right now. As the same time, training geared towards healthcare professionals at hospitals is being given (doctors specialising in different fields: oncology, nephrology, dermatology, etc.).
Publications in journals
B. Calvo, L. Zuñiga. "EU's New Pharmacovigilance Legislation: Considerations for Biosimilars". Drug Safety 37: 9-18 (2014). http://www.ncbi.nlm.nih.gov/pubmed/24190573. F.I.: 3,4
B. Calvo, L. Zuñiga. "The US approach to biosimilars: the long-awaited FDA approval pathway". BioDrugs 26: 357-361 (2012). http://www.ncbi.nlm.nih.gov/pubmed/23030677. F.I: 2,8
B. Calvo, L. Zuñiga. "Therapeutic monoclonal antibodies: strategies and challenges for biosimilars development". Current Medicinal Chemistry 19: 4445-4450 (2012). http://www.ncbi.nlm.nih.gov/pubmed/22978327. F.I: 4,1
L. Zuñiga, B. Calvo. "Biosimilars: pharmacovigilance and risk management". Pharmacoepidemiology and Drug Safety 19: 661-669 (2010)
http://www.ncbi.nlm.nih.gov/pubmed/20583204
Publications in books
B. Calvo. "Current regulatory landscape for biosimilars approval" in Development of Biosimilars, Ed. Paul Declerck. Future Science Editions. London. 2014. (Due to be published soon).
B. Calvo, L. Zúñiga. "Risk Management Plan and Pharmacovigilance system. Biopharmaceuticals: biosimilars" in: Risk Management Trends. Ed. G.Nota. InTech. ISBN 978-953-307-314-9. http://www.intechopen.com. 2011, pp. 251-266. (4,000 downloads).
After generics it's the turn of biosimilars, a budding market
What can be regarded as pioneering research worldwide has been conducted by the UPV/EHU-University of the Basque Country within the European regulatory framework for biosimiliar drugs
2014-09-09
[Attachments] See images for this press release:
ELSE PRESS RELEASES FROM THIS DATE:
Carnegie Mellon's smart headlights spare the eyes of oncoming drivers
2014-09-09
PITTSBURGH—A smart headlight developed at Carnegie Mellon University's Robotics Institute enables drivers to take full advantage of their high beams without fear of blinding oncoming drivers or suffering from the glare that can occur when driving in snow or rain at night.
The programmable headlight senses and tracks virtually any number of oncoming drivers, blacking out only the small parts of the headlight beam that would otherwise shine into their eyes. During snow or rain showers, the headlight improves driver vision by tracking individual flakes and drops in the immediate ...
New molecular target is key to enhanced brain plasticity
2014-09-09
As Alzheimer's disease progresses, it kills brain cells mainly in the hippocampus and cortex, leading to impairments in "neuroplasticity," the mechanism that affects learning, memory, and thinking. Targeting these areas of the brain, scientists hope to stop or slow the decline in brain plasticity, providing a novel way to treat Alzheimer's. Groundbreaking new research has discovered a new way to preserve the flexibility and resilience of the brain.
The study, led by Tel Aviv University's Prof. Illana Gozes and published in Molecular Psychiatry, reveals a nerve cell protective ...
Sharks in acidic waters avoid smell of food
2014-09-09
VIDEO:
A smooth dogfish shark attacks an odor cue at at Woods Hole Oceanographic Institution.
Click here for more information.
The increasing acidification of ocean waters caused by rising atmospheric carbon dioxide levels could rob sharks of their ability to sense the smell of food, a new study suggests.
Elevated carbon dioxide levels impaired the odor-tracking behavior of the smooth dogfish, a shark whose range includes the Atlantic Ocean off the eastern United States. Adult ...
Shared pain brings people together
2014-09-09
What doesn't kill us may make us stronger as a group, according to findings from new research published in Psychological Science, a journal of the Association for Psychological Science.
The research suggests that, despite its unpleasantness, pain may actually have positive social consequences, acting as a sort of "social glue" that fosters cohesion and solidarity within groups:
"Our findings show that pain is a particularly powerful ingredient in producing bonding and cooperation between those who share painful experiences," says psychological scientist and lead researcher ...
Exercise before school may reduce ADHD symptoms in kids
2014-09-09
EAST LANSING, Mich. – Paying attention all day in school as a kid isn't easy, especially for those who are at a higher risk of ADHD, or attention deficit hyperactivity disorder.
A new study from Michigan State University and University of Vermont researchers shows that offering daily, before-school, aerobic activities to younger, at-risk children could help in reducing the symptoms of ADHD in the classroom and at home. Signs can include inattentiveness, moodiness and difficulty getting along with others.
The study can be found in the Journal of Abnormal Child Psychology.
"Early ...
Scientists discover hazardous waste-eating bacteria
2014-09-09
Tiny single-cell organisms discovered living underground could help with the problem of nuclear waste disposal, say researchers involved in a study at The University of Manchester.
Although bacteria with waste-eating properties have been discovered in relatively pristine soils before, this is the first time that microbes that can survive in the very harsh conditions expected in radioactive waste disposal sites have been found. The findings are published in the ISME (Multidisciplinary Journal of Microbial Ecology) Journal.
The disposal of our nuclear waste is very challenging, ...
Estrogen receptor expression may help explain why more males have autism
2014-09-09
AUGUSTA, Ga. – The same sex hormone that helps protect females from stroke may also reduce their risk of autism, scientists say.
In the first look at a potential role of the female sex hormone in autism, researchers at the Medical College of Georgia at Georgia Regents University have found expression of estrogen receptor beta – which enables estrogen's potent brain protection – is significantly decreased in autistic brains. The receptor also plays a role in locomotion as well as behavior, including anxiety, depression, memory, and learning.
"If you ask any psychiatrist ...
Phosphorus a promising semiconductor
2014-09-09
Defects damage the ideal properties of many two-dimensional materials, like carbon-based graphene. Phosphorus just shrugs.
That makes it a promising candidate for nano-electronic applications that require stable properties, according to new research by Rice University theoretical physicist Boris Yakobson and his colleagues.
In a paper in the American Chemical Society journal Nano Letters, the Rice team analyzed the properties of elemental bonds between semiconducting phosphorus atoms in 2-D sheets. Two-dimensional phosphorus is not theoretical; it was recently created ...
A system that facilitates malware identification in smartphones
2014-09-09
Malware is a type of malicious program whose general aim is to profit economically by carrying out actions without the user's consent, such as stealing personal information or committing economic fraud. We can find it "in any type of device ranging from traditional cell phones to today's smartphones, and even in our washing machine," explained one of the researchers, Guillermo Suarez de Tangil, from the Computer Science Department at UC3M.
With the massive sales of smartphones in recent years (more than personal computers in all of their history), malware developers ...
Testing the fossil record
2014-09-09
Palaeontologists have developed methods to try to identify and correct for bias and incompleteness in the fossil record. A new study, published on 4 September 2014 in the journal Nature Communications, suggests that some of these correction methods may actually be misleading. The work is led by Dr Alex Dunhill (University of Leeds, formerly at the Universities of Bath and Bristol), together with Hannisdal (University of Bergen) and Professor Michael Benton (University of Bristol).
Back to the origin of animals
"The Earth keeps changing. Life keeps evolving. And there ...
LAST 30 PRESS RELEASES:
Computational biology paves the way for new ALS tests
Study offers new hope for babies born with opioid withdrawal syndrome
UT, Volkswagen Group of America celebrate research partnership
New Medicare program could dramatically improve affordability for cancer drugs – if patients enroll
Are ‘zombie’ skin cells harmful or helpful? The answer may be in their shapes
University of Cincinnati Cancer Center presents research at AACR 2025
Head and neck, breast, lung and survivorship studies headline Dana-Farber research at AACR Annual Meeting 2025
AACR: Researchers share promising results from MD Anderson clinical trials
New research explains why our waistlines expand in middle age
Advancements in muon detection: Taishan Antineutrino Observatory's innovative top veto tracker
Chips off the old block
Microvascular decompression combined with nerve combing for atypical trigeminal neuralgia
Cutting the complexity from digital carpentry
Lung immune cell type “quietly” controls inflammation in COVID-19
Fiscal impact of expanded Medicare coverage for GLP-1 receptor agonists to treat obesity
State and sociodemographic trends in US cigarette smoking with future projections
Young adults drive historic decline in smoking
NFCR congratulates Dr. Robert C. Bast, Jr. on receiving the AACR-Daniel D. Von Hoff Award for Outstanding Contributions to Education and Training in Cancer Research
Chimpanzee stem cells offer new insights into early embryonic development
This injected protein-like polymer helps tissues heal after a heart attack
FlexTech inaugural issue launches, pioneering interdisciplinary innovation in flexible technology
In Down syndrome mice, 40Hz light and sound improve cognition, neurogenesis, connectivity
Methyl eugenol: potential to inhibit oxidative stress, address related diseases, and its toxicological effects
A vascularized multilayer chip reveals shear stress-induced angiogenesis in diverse fluid conditions
AI helps unravel a cause of Alzheimer's disease and identify a therapeutic candidate
Coalition of Autism Scientists critiques US Department of Health and Human Services Autism Research Initiative
Structure dictates effectiveness, safety in nanomedicine
Mission accomplished for the “T2T” Hong Kong Bauhinia Genome Project
Study identifies how malaria can lead to childhood cancer
An earth-abundant mineral for sustainable spintronics
[Press-News.org] After generics it's the turn of biosimilars, a budding marketWhat can be regarded as pioneering research worldwide has been conducted by the UPV/EHU-University of the Basque Country within the European regulatory framework for biosimiliar drugs