Health experts have urged the government to follow WHO guidelines while registering biologics as a slight discrepancy in manufacturing can cost precious lives of patients. It has been learnt that the Drugs Regularity Authority Pakistan (DRAP) has given approval for importing from a neighbouring country a biological drug in its 260th meeting but it does not meet WHO's mandatory guidelines for manufacturing bio-similar products.
"There is a difference between drugs and biologics, which are manufactured in a living system such as a micro-organism, or plant or animal cells," said health experts. "Biologics are very large, complex molecules or mixtures of molecules and many biologics are produced using recombinant DNA technology. "A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process," said the experts.
"The WHO has given a complete mechanism when it comes to production and approval for biologics. Our authorities should be extra vigilant while registering biological medicines and should strictly follow the WHO guidelines which are also part of our own Drug Act," the experts added.
As per the WHO guidelines approved by its expert committee on biological standardisation in October 2009, biologic products have a successful record in treating many life-threatening and chronic diseases. However, their cost has often been high, thereby limiting their access to patients, particularly in developing countries. Recently, the expiry of patients and/ordata protection for the first major group of originator's biologics has ushered in an era of products that are designed to be 'similar' to a licensed originator product commonly called bio-similar. These bio-similar rely, in part, for their licensing on prior information regarding safety and efficacy obtained with the originator products. The clinical experience and established safety profile of the originator products should contribute to the development of bio-similar biologics.
The WHO guidelines state that "the approach established for generic medicines is not suitable for development, evaluation and licensing of bio-similar since biologics consist of relatively large and complex proteins that are difficult to characterise."
As per the WHO guidelines, there is a mandatory requirement of "head-to-head comparison of a biological product with a licensed originator product with the goal to establish similarity in quality, safety, and efficacy. Products should be compared in the same study using the same procedures."
If a biological product intended to be a copy of a reference product is approved but does not meet the WHO criteria for bio-similar - not demonstrated to be similar with regard to quality, non-clinical properties as well as clinical safety and efficacy in head to head comparative studies - it should not be called a bio-similar. Rather, it should be called a non-comparable biologic (NCB). Unless a manufacturer provides all necessary scientific evidence qualifying its product as a bio-similar, any approval of a NCB should be reassessed by the National Health Agency because of the potentially significant differences regard quality, safety and efficacy between the NCB and the reference biological product. One of the core functions of DRAP is to implement the internationally-recognised standards, especially when it comes to registration of highly complex biological products.