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[e-drug] The Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health

E-DRUG: The Utrecht Centre of Excellence for Affordable Biotherapeutics for 
Public Health
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[all the texts below are sourced from 
http://www.uu.nl/en/organisation/utrecht-centre-of-excellence-for-affordable-biotherapeutics/
 
Copied as fair use. WJB]

The WHO and University Utrecht (Netherlands) today announced the set up of a 
new WHO collaborating centre:

The Utrecht Centre of Excellence for Affordable Biotherapeutics for Public 
Health (UCAB) is the result of a collaboration between Utrecht University and 
the World Health Organisation. UCAB is a non-profit foundation that aims to 
facilitate the development and distribution of high quality and affordable 
biotherapeutics in low and middle income countries.

UCAB

Mission: Our mission is to improve global health by helping to make high 
quality and affordable biotherapeutics accessible to patients throughout the 
world in a sustainable fashion.

Why a centre of Excellence?  Unmet medical needs in Low and Middle Income 
Countries

Since the market authorisation of the first recombinant insulin in 1982 and the 
first monoclonal antibody in 1992, biological therapeutics (biologicals) have 
been developed to treat a variety of diseases, including cancer and autoimmune 
diseases. Although the use of biopharmaceuticals has expanded in high income 
countries, low and middle income countries (LIMCs) have been largely devoid of 
these products, notwithstanding a considerable medical need1. As the first 
biopharmaceuticals products have lost, or are about to lose their patent 
protection, opportunities have arisen to develop affordable copy versions 
(biosimilars) of these products. However, currently available biosimilars are 
still too expensive for most patients in LMICs.

In various countries cheaper copies of biological products have been available 
for many years, mainly predating the existence of biosimilar regulatory 
guidelines. These products mostly did not complete the rigorous comparability 
exercise that is advocated in the current WHO guidelines and some may be of 
questionable quality. It is thus of the utmost importance that the products 
that are available in LMICs adhere to international quality standards.

1. Lopes Gde, L.,Jr, de Souza, J. A. & Barrios, C. Access to cancer medications 
in low- and middle-income countries. Nat. Rev. Clin. Oncol. 10, 314-322 (2013).

The first project will be to produce the monoclonal antibody palivizumab, used 
in the prevention of RSV respiratory infections.

RSV

Respiratory syncytial virus (RSV) is the leading cause of hospitalisations in 
infants and young children and the leading cause of acute lower respiratory 
infections (ALRI) in children globally.  The annual global incidence of RSV 
infection has been estimated at 64 million and is estimated to cause 
approximately 33.8 million new episodes of ALRI in children annually, of which 
96% occur in developing countries. In addition, RSV is the most common viral 
cause of death in children younger than 5 years of age and has been estimated 
to cause up to 199,000 deaths per year. As a comparison, global measles deaths 
are estimated at 164,000. Infections are more severe in premature infants and 
in those with subjacent illness (such as chronic lung disease, congenital heart 
disease and HIV).1 Globally, about 15 million neonates are born prematurely 
(defined as before 37 weeks of gestation) each year, which corresponds to more 
than one in 10 of all neonates.2 So far, no safe and efficacious vaccine 
against RSV has been approved. Although some vaccines are under development, it 
remains uncertain if these will prove to and be effective in protecting preterm 
or immunocompromised infants. 

Palivizumab

Currently there is only one medical intervention available against RSV: Monthly 
intramuscular injections of the monoclonal antibody palivizumab (Synagis®) to 
high-risk infants to serve as a prophylaxis for reducing the incidence of 
hospitalisation. In countries with a clear seasonal pattern the treatment is 
generally recommended during the winter months or rainy season and is 
authorised to be administered to neonates born less than 35 weeks gestation. 
However, the cost of treatment with palivizumab has been estimated at around € 
4000 per season (five doses)3, with some estimates as high as US$ 9,615 per 
season. Set at this price, palivizumab is out of reach for many patients in 
LMICs. The patent on the technology will expire in 2015, opening up 
opportunities for biosimilar versions on the market. However, so far there has 
been little interest from biosimilar manufacturers in developing this product.

1. Tempia, S. et al. Mortality associated with seasonal and pandemic influenza 
and respiratory syncytial virus among children <5 years of age in a high HIV 
prevalence setting--South Africa, 1998-2009. Clin. Infect. Dis. 58, 1241-1249 
(2014).
2. Prescott, W. A.,Jr, Doloresco, F., Brown, J. & Paladino, J. A. Cost 
effectiveness of respiratory syncytial virus prophylaxis: a critical and 
systematic review. Pharmacoeconomics 28, 279-293 (2010).
3. Nuijten, M. J. & Wittenberg, W. Cost effectiveness of palivizumab in Spain: 
an analysis using observational data. Eur. J. Health. Econ. 11, 105-115 (2010).

About Biosimilars

Biosimilars are copy versions of biological products whose patents have 
expired. Unlike small molecules, biologicals are very large and intricate 
molecules that are subject to extensive post-translational modifications that 
are sensitive to differences in manufacturing conditions. Therefore, biological 
products are complex mixtures that cannot be completely characterised using 
existing analytical methods. Because of these limitations, biosimilar 
regulatory pathways have been established throughout the world. These pathways 
allow the authorisation of a biopharmaceutical through the demonstration of 
‘biosimilarity’ to an already approved ‘reference product’ by completing an 
extensive ‘comparability exercise’.

The extent of this comparability exercise differs globally, but an increasing 
number of countries have adopted regulations modelled after the WHO guidelines 
on evaluation of similar biotherapeutic products (SBPs). These guidelines 
advise a stepwise approach, including the provision of a full quality dossier, 
appropriate nonclinical studies, pharmacokinetic and pharmacodynamic studies, 
and, finally, comparative clinical studies (either confirmatory PK/PD, or 
therapeutic efficacy studies) to confirm a comparable benefit risk profile to 
the chosen reference product.

Costs of biotherapeutics

Currently authorised, top selling monoclonal antibodies are sold at prices 
ranging from €1000-€100.000 per year, whereas the estimated costs of goods for 
producing monoclonal antibodies are estimated at around 2.3% of the sales 
price.1 Clearly, there is great opportunity to reduce the costs of these 
products once their patents expire.

However, developing biosimilars requires considerable technological expertise. 
Compared to small molecule generics, the development process is long (5-10 
years) and costly, with estimated investment costs ranging from US$ 40-200 
Million for a biosimilar. Biosimilar products authorised in Europe are being 
sold at prices that are only 30%-40% lower than the innovator.2  While this may 
lead to considerable cost savings, such high costs still put these products out 
of reach for most patients in LMICs. In order to improve access to 
biotherapeutics in LMICs, the costs of these treatments require substantial 
reductions.

1. Kelley, B. Industrialization of mAb production technology: the bioprocessing 
industry at a crossroads. MAbs 1, 443-452 (2009).
2. IMS health. Shaping the biosimilars opportunity: A global perspective on the 
evolving biosimilars landscape. Available from: 
http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf
 [Accessed 17 July 2012]. (2011).

The driving force behind the new Centre of Excellence is Huub Schellekens, its 
Director.

Huub Schellekens is professor of Pharmaceutical Biotechnology at Utrecht 
University in the Netherlands. He teaches Medical Biotechnology at the 
Innovation Studies Group and has a research position at the Department of 
Pharmaceutical Sciences at the same university.

E-drug welcomes more discussion on biosimilars

Wilbert

---
Wilbert Bannenberg, E-drug moderator
wjb@wxs.nl



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