SIMILAR BIOLOGICS PART IV (Concluded)

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.