‘Relaxing norms for biosimilars risks safety’

A section of scientists and doctors has urged the Union Health Ministry and the Department of Biotechnology not to dilute norms for biosimilars (a biological medicine that is similar to an already approved biological medicine) as any such loosening of norms, in a bid to make such treatments affordable, risks compromising patient safety.

“Even when regulations are in place, about 3% of drugs are found to be of non-standard quality and the figure is higher (10%) for drugs supplied to the public sector,” said Amitav Banerjee, Professor, Community Medicine and a Clinical Epidemiologist, referring to demands from some NGOs to ease guidelines for biosimilars with a view to both quickening their time to market availability and helping lower the cost of such medicines.

“Throwing the market open without proper quality checks for biosimilars, particularly in a country with a poorly functioning pharmacovigilance system to closely monitor long-term adverse events, will be hazardous,” Dr. Banerjee cautioned.

He said for biosimilars that were copies of original innovator products, more studies were needed for regulatory approval to ensure that differences, if any, did not affect patient safety or drug efficacy, particularly since they were not generics.

Anurag S. Rathore, Professor Biopharmaceutical Technology, IIT-Delhi said: “Indeed, clinical trials continue to be the single largest contributor to the development and commercialisation of a biotherapeutic product. This is even true for a biosimilar, class of compounds for which the quantum of required clinical trials is already substantially reduced”.

“It is also true that biosimilars cost significantly more than their pharmaceutical generic counterparts, thereby impacting their affordability and accessibility,” Mr. Rathore observed.  “These facts have been fuelling calls for the reduction or even elimination of clinical trials , as this would substantially lower the cost of manufacturing and make them more affordable. The regulators need to keep a delicate balance between affordability and patient safety,” he added.

“If clinical trials are significantly curtailed or worse, totally eliminated, the probability of getting a therapeutic product with inadequate safety and/or efficacy increases,” he warned.

Prof. Bejon Kumar Misra, founder director, Patient Safety and Access Initiative of India Foundation, an organisation that works in the area of patient safety, said: “Clinical trials and safety efficacy studies are vital requisites to ensure products launched in the market are safe and efficacious. The safety of patients cannot be negotiated for the sake of affordability”.

“There is no denying that biosimilars can significantly bring down the price of essential biologics that are used for critical diseases including cancer, but that does not mean biosimilars are allowed in the market without adequate safety studies,” Mr. Misra added.

“In fact, because biologics are complex and difficult to develop, it is important that biosimilars undergo rigorous testing and clinical scrutiny to ensure they are safe and efficacious,” he stressed. “Any slips, in the name of cost-cutting, could prove to be fatal for patients and for the industry,” he added.