Advanced biological drugs are manufactured by deploying recombinant DNA(r DNA) technology. Only over the past three decades the development of such drugs has experienced continuous growth. Chemically, such biologics are complex molecular substances which are produced by and within living cells of prokaryotic or eukaryotic origin. For the production of certain of such drugs, transgenic animals and plants have been used. The cellular machinery of living entities synthesize such substances based on the ‘instructions’ planted by tools and methods by the scientists within the living entities by utilizing r DNA technology. These molecular substances are 100 to 1000 times bigger in size as compared to the active pharmaceutical ingredients (APIs) that are used for the manufacture of generic pharmaceutical formulations.
Almost all such biologically manipulated man-made molecular substances are initially protected under the Intellectual Property Rights (IPR) by the inventors or their assignees. IPR stipulates protection in countries where such rights have been taken. IPR becomes an expensive way to protect an invention if the invention is not exploited by the owner; many inventors therefore do not invest to protect their invention in every country. Earlier, protection was usually taken and ensured by the inventors in countries where they felt that the invention was saleable and the demands for the products emanating from the exploitation of the invention were anticipated to be high. Presently however the span of protection of inventions that are anticipated to be industrially exploitable fast is extended on a much wider canvas to cover as many countries as have demand for such products and where scientific capabilities of manufacturing such products exist in their territories, especially after the enactment of the provisions of World Trade Organization in Member countries. For the protection of inventions in Member countries, WTO has a uniform provision. Protein-based biological drugs comprising mainly of simple or carbohydrate ligand-modified substances have a wide range of therapeutic applications. Proteins are polymers of alpha amino (most frequently L-α-amino) acids with defined sequences linked by peptide bonds and having usually more than forty alpha amino acids in each molecule but can go even up to 2000 amino acids or more. The business on recombinant protein-based biological drugs is very large in terms of global sale and therefore entrepreneurs have eyes on this business. The proprietary rights on such biological drugs are vested upon the inventors or their assignees as per the conditions of IPR.
The contributions of the modern biologics in human welfare have been enormous. These biologics have assisted significantly during the last three decades in treating several chronic diseases including cancer. With time as more inventions are emanating in this area, the usefulness of such substances continues to increase. Utilization of various kinds of insulin manufactured through recombinant DA technology along with other anti-diabetic drugs have resulted in the control of plasma glucose within healthy limits and death rates of diabetic patients between 1997 and 2006 have substantially fallen. Insulin has played a major role in such endeavor. Use of a large number of biological medicines to treat rheumatoid arthritis has enabled clinical remission of the disease almost completely and has contributed to great human benefits; the results with etanercept had been amazing. Treating cardio-vascular diseases by use of biological medicines such as thrombolytic agents and monoclonal have saved many lives. Biological drugs have resulted in reduction in death rates from cardio-vascular diseases by about 31% between 1998 and 2008 in USA. Development and use of erythropoietin produced by modern biotechnology has reduced the need for blood transfusion in anemic patients of different kinds including cancer patients and have reduced hospital days, thereby benefitting the society. This medicine has also prolonged lives of many terminally ill patients. Incurable viral diseases such as HBV and HCV have been controllable by use of a wide range of modern biologics are continuing to provide substantial life expectancy gains. In US, the death due to all kinds of cancer has come down steadily by 1.5% per year from and during 2000-2013, which is a reduction of around 17% over this period and is considered highly significant. Overall, the use of biological drugs has contributed to increasing life expectancy, decreasing disability and improvement in the quality of life. Therefore, wherever the burden of incidence of such diseases is showing increase, societal efforts require intensification to enable abundant availability and use of such medicines to the affected. Presently, because of increased costs of such medicines and the limited means of the payers in the poor countries, the situation becomes most vulnerable in families having to pay for the costs. The governments in poor countries also do not have adequate funds to make the necessary supply of such drugs to its citizens and in most countries the patients are the payers for the cost of their treatment.
With the passage of time, when such biological medicines get patent-expired, other new companies would come up and 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 proving and providing properties of the products manufactured by the new supplier/s as very similar to the products of the inventor through processes of comparison of the products physico-chemically, biologically and through accepted but limited clinical studies on human subjects. Such products introduced by new companies later on are named differently in different countries such as “biosimilars”, “biosimilar products”, “follow-on biologics”, “similar biologics”, “biologics against new biologics”, “biocomparables” and “medicamento biologic similar”. In India, these products are named as “similar biologics”. In several international journals, such products have been termed as “Copycat” and “Knockoff”.
By 2020, a dozen of “inventor’s biologicals” having estimated market sale-value of over USD 79 billion are going out of protection of IPR. This would drive entrepreneurs to enter in to the field and the prices are going to crash considerably due to market competition. In course of time more numbers of “similar biologics” would go out of IPR. Different proactive governments and the regulatory agencies all over the world are trying to harness the existing and future opportunities by creating regulatory guidelines to ease faster authorization of use of “similar biologics” in their territories. A small number of “similar biologics” have been approved for use in different countries all over the major parts of the world. More efficient technologies for manufacture of “similar biologics” are also getting developed. Together, these efforts are anticipated to ease the availability of “similar biologics” at more affordable prices to the users/ payers the world over.