Thursday, September 17, 2015
SIMILAR BIOLOGICS PART I
SIMILAR BIOLOGICS PART I
Recombinant DNA products in the pharmaceutical industry in the global context refer to biologics that are medicines manufactured and marketed by the inventors. All such products are initially patented and the product-proprietary rights are vested upon the inventors. With the passage of time, as and when such medicines are patent-expired, other new companies start producing them. Worldwide, the accepted practice for adoption of such patent-expired products for human use in medicines from manufacturers other than the original inventors are based upon providing properties of the product manufactured by the new supplier/s as equivalent to the product of the inventor through processes of identification of the product physico-chemically, biologically and through accepted clinical studies on human subjects. Such products introduced by new companies are named in different countries as “biosimilar products”, “follow-on biologics” and “similar biologics”. In India, these products are known as “similar biologics”.
The global market for “similar biologics” is anticipated to grow to USD 10 billion in 2015. (Source: www.ibef.org). This growth is largely driven by “similar biologics” going off patent by 2020 worth value of USD 67 billion. (Source: http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020). The number of companies likely to enter into “similar biologics” market would however be large even though the numbers would be limited, as the lead time is high and would require high developmental costs. Such “similar biologics” are “different” from “patent-expired small molecules”, where developmental requirements are much simpler. “Patent-expired” small molecules are parts of “generic drugs” manufacturing outfits.
The “similar biologics” industry is fast growing the world over and has a strong economic value proposition as the profitability prospects are very high. “Similar biologics” are medicines that are more effective than “generic” drugs and treatment with “similar biologics” hold the hope of not only providing increased longevity but also of extending better quality of life, especially in situations of chronic diseases including diabetes, cardio-vascular diseases, arthritis and a wide range of cancers. Setting up of “similar biologics” industry would ensure the availability of such drugs from multiple sources resulting in market competition and therefore, the prices would also be cheaper and more affordable than when supplied by the “inventors”.
Worldwide, because of large and growing market of “similar biologics”, the regulatory frameworks of all major countries are newly emerging to provide fast structured approvals so as to enable the consumers to get the benefits of use of such medicines within a territory. There is however considerable resistance from certain countries particularly from the US regulators to formally approve the production of “similar biologics” from new “similar biologics” manufacturers. Such steps and conditions would not hold for long as the healthcare costs in any country need to be rationalized and made affordable to suit the needs of poor and middle class people too, especially in situations where medical costs are not borne by the state or where patients are not fully covered with medical insurances.
The competitive pressure as well as the market for “similar biologics” varies from country to country. World over, there are “regulated markets” as well as “semi-regulated markets” for “similar biologics”. The following figure depicts the present world scenario on “similar biologics” usage:
Adopted and modified by Dr. P.K. Ghosh from IBEF Report at www.ibef.org