Biosimilars: Hope and concern.

ABSTRACT

As patents of the first introduced biologic therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the original agent. These products are called biosimilars. Upon patent expiration, biosimilars would hopefully be a cheaper alternative to the original agent and that is the main reason for their existence. Although the financial aspect is similar to generics, the complex nature of these products generates the need for a distinct regulatory environment. Biosimilars are produced by DNA technology in bacteria, plant cells, or animal cells, while generics are produced by chemical synthesis. Details in the process of synthesis, selection of the microorganism, protein extraction, purification and manufacturing, affect the precise nature of the end product. Monoclonal antibodies are large proteins with four polypeptide chains and interact variably with each other and with the environment. It is important for payors to realize that biosimilars are different from generics; therefore, they need to develop different set of rules for approving, registering, and dispensing biosimilars. Regulators ought to respect the physicians' request for non-interchangeability and facilitate in any possible way of traceability. Such regulations along with a rigorous pharmacovigilance program will satisfy the concerns for true equivalence in activity and long-term safety. This is the only way to accumulate over time reliable safety information for new biosimilars. In conclusion, the wish born by the medical community and the society for a more affordable health system triggers the emergence of biosimilars, which could meet that goal if properly regulated.