The
information provided in earlier parts are indications that countries are greatly
interested in introducing “similar biologics” within their territory. Defined regulatory
pathways for introducing “similar biologics” in different countries are paving
the way towards the goal of introducing “similar biologics” within their
territories in the shortest possible time. Asian countries as well as South
American countries are rich in technical skills in handling diverse aspects of
fermentation based technologies with proficiencies in downstream processing
techniques. Most of these countries have taken steps to introducing “similar
biologics” within their territory by announcing regulatory procedures. Entrepreneurs
from all over the world can now take bold steps to set up integrated facilities
for the production of some of these “similar biologics” within these territories
with eyes on capturing a part of the global market. If efforts are made
sincerely in these directions and if access to investments to the tune of USD
25-40 million is made available and further if concerted efforts are made over
a period of 3-5 years to introduce “similar biologics” by a group of professionals,
it would be an excellent business proposition in these territories.
India
has already made a beginning in this direction. There are presently 11
companies that are manufacturing “similar biologics”; there are other units
which are importing and selling and thereby acquiring experience in sale which
is indeed a tough experience to master. Of the major manufacturing companies in
India, are Intas Pharmaceuticals Ahmedabad which has developed its own core
competence for handling different aspects of manufacture of “similar
biologics”. Intas had also signed an agreement with Canadian drug major Apotex
Inc. in May 2008, to co-develop and market the low-cost version of a biotech
cancer medicine filgrastim (G-CSF) in North America and Europe. Dr. Reddy’s
Labs, Hyderabad has developed competence in production of a wide range of
“similar biologics” including Darbepoetin Alpha, Herceptin/Trastuzumab, IFN
PEG, Rituximab etc. Biocon India, Bangalore is engaged in the production of Insulin,
Bevacizumab, Granulocyte Stimulating Factor (GSF), Pegylated Granulocyte Stimulating
Factor (Peg-GSF), Herceptin/Trastuzumab etc. They have teamed up with Mylan
Inc., USA as also with a Cuban company. Reliance Life Sciences, Navi Mumbai is
engaged in the production of Erythropoietin (EPO), Granulocyte Stimulating
Factor (GSF), IFN Alpha, IFN PEG, Infliximab, Palivizumab/Synagis, Rituximab,
Streptokinase, Tissue plasminogen activator (t-PA) etc. Bharat Biotech,
Hyderabad is engaged in the production of Epidermal Growth Factor (EGF), Human
Growth Hormone (hGH), Palivizumab/Synagis etc. Cipla, Mumbai is engaged in the marketing
of a selected range of “similar biologics” including Etanercept based on collaboration
with foreign companies such as Shanghai CP Guojian Pharmaceuticals Co. Ltd.,
China. Wockhardt, Aurangabad produces a large number of “similar biologics”
based on technologies originally imported from Germany; the products include
insulin, cytokines, erythropoietin etc.
Production
of “similar biologics” includes the stages of development/procurement of host
cells, establish a host cell bank, develop facilities for growing the host
cells where the target “similar biologics” proteins are secreted/included as “inclusion
bodies” within the host cells; isolation of the target proteins; purification; analysis;
formulation development and finally storage and handling followed by marketing.
For
faster development in any region, genetically modified host cells could be
procured through collaboration and thereafter these could be multiplied to
produce the target “similar biologics”, which would then be transformed into
formulations. A developmental laboratory set up within the facility with a
group of competent and highly modified personnel can convert the procured
technologies into usable ones, within the shortest possible time. Examples are
the many Indian companies that have gone into production during the last one
decade or so.
Presently,
pegylation technologies are fast catching up. Pegylation of already used
biologics is showing an upward global trend as pegylation process enhances the
circulation time of biologics within the body and thus is available for
manifesting biological activity for longer time. Pegylation technologies are
available for purchase. Technologies for pegylated products of specific
biologics are also available for purchase. Presently, the world trend is to
introduce a biologically active molecule in the form of its “pegylated”
version. Pegylation is a chemical reaction for introducing a highly hydrophilic
moiety within the backbone of the “similar biologics” to make the “similar
biologics” more effective as by pegylation, the clearance of “similar
biologics” from the body is substantially delayed. At the same time, pegylated
“similar biologics” do not lose their specific therapeutic activities.
Pegylated
erythropoietin, Interferon alpha 2b and G-CSF have already been approved by US
FDA and therefore introduction of such products would not pose any problem for
introduction as “similar biologics” from and within many other countries.
There
are presently more than 150 “similar biologics” which include human proteins
such as insulin, erythropoietin, cytokines and a host of other products besides
the more recently introduced monoclonal antibodies which are utilized for
treating different life threatening conditions. “Similar Biologics” are better
therapeutic agents than the generic drugs (which are small molecules) in most
situations where the ailments are chronic and life threatening.
“Similar
Biologics” as such or their pegylated forms are the future for the treatment of
chronic diseases. These are presently the most important alterative for
increasing the life span of individuals suffering from chronic life threatening
diseases. Use of these medicines would also improve the quality of life of the patients.
Such products are expected to reign the world for at least another 2-3 decades
till better alternatives come out from nucleic acid stretches as medicines or stem
cell therapy or some other most modern therapy that are yet far away for
deployment as therapies for treating diseases of human kind.
