The term “biosimilar” refers to a biological product that is highly similar to a licensed biological agent (reference or originator product) with no clinically meaningful differences in terms of safety, purity, or potency. Biological agents or “biologics” are widely used in oncology practice for cancer treatment and for the supportive management of treatment-related side effects.
As biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower-cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development. As such the Indian guidelines on similar biologics are comparable in many respects to biosimilar guidelines of USA and EU. India has adopted a “sequential approach” (like “stepwise approach” – US and EU) to market biosimilar products.
|MOLECULAR WEIGHT||~150 Daltons||~150,000 Daltons|
|STRUCTURE||Simple and well-defined||Complex with potential structural variations|
|MANUFACTURING||Predictable chemical process to make identical copy||Specialized biological process to make similar copy|
|COMPLEXITY||Easy to fully characterize||Difficult to characterize|
|STABILITY||Relatively stable||Sensitive to storage and handling conditions|
|ADVERSE IMMUNE REACTION||Lower potential||Higher potential|
|MANUFACTURING QUALITY TESTS||≤ 50||≥ 250|
|APPROVAL REQUIREMENTS||Small clinical trials in healthy volunteers||Large clinical trials in patients|
With Biosimilars, not only will patients have more treatment options, but they will also potentially have the ability to get the medications they need for serious disorders at much lower costs than the original biologics. With biosimilars becoming more widely available, consumers can expect the same efficacy, safety and reliability as the original medication at a reduced price.