E-DRUG: Access to alternative biopharmaceuticals in low- & middle- income countries
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In recent years, biotherapeutics have gained a significant role in the
management of life threatening diseases. However, many patients in low- and
middle-income are not able to afford them due to the very high prices.
Production of copies of these medicines, mostly called biosimilars, has
received attention from both manufacturers and regulatory agencies
worldwide.
Despite the fact that some international organizations such as WHO and EMA
have issued guidelines for regulation of these alternative
biopharmaceuticals, due to a lack of sufficient resources and expertise,
design and implementation of a comparative clinical study, as proposed by
WHO or EMA guidelines,in low- or medium-resourced countries is not
feasible. It is therefore questioned whether WHO guidelines are in line
with the needs, capabilities and interests of national pharmaceutical
markets in low- and medium- resourced countries.
It seems that the guideline should be balanced between assured safety and efficacy,
and timely availability of these life-saving medicines for these countries. One
approach is that alternative biopharmaceuticals could be developed without
undergoing lengthy and costly clinical comparative trials and could instead
have either a conditional approval based on sufficient efficacy and safety
data in real life or undergo a less costly demonstration of efficacy and
safety by using historical data from innovator products as a comparison.
It is a general consensus that alternative biopharmaceuticals could improve
accessibility and affordability of these medicines. Therefore, an
alternative approach could be that - following approval of quality control
and *in vitro *parameters for alternative biopharmaceuticals according to
internationally acceptable standards- instead of requesting a comparative
clinical trial, regulatory authorities could issue a time limited, e.g. one
year, marketing authorization for the product to be used in few
well-established medical centres as a phase 4 clinical study.
During this period, the product will be administered under direct surveillance of
regulatory authorities and the efficacy data or possible adverse effects,
including immunogenicity reactions, will be monitored meticulously by
regulatory authorities. If during this period all results were
satisfactory, the marketing authorization will be expanded; if not, the
product will be removed from the market.
To read full text:
http://gabi-journal.net/access-to-alternative-biopharmaceuticals-in-low-and-middle-income-countries.html
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Dr Abdol Majid Cheraghali
Tehran- Iran
cheraghali@fdo.gov.ir
Majid Cheraghali <majidcheraghali@gmail.com>