A bit of scientists and medical doctors has urged the Union Health Ministry and the Department of Biotechnology to not dilute norms for biosimilars (a organic drugs that’s just like an already accredited organic drugs) as any such loosening of norms, in a bid to make such therapies inexpensive, risks compromising affected person security.
“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,” mentioned Amitav Banerjee, Professor, Community Medicine and a Clinical Epidemiologist, referring to calls for from some NGOs to ease tips for biosimilars with a view to each quickening their time to market availability and serving to decrease the price 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 mentioned for biosimilars that had been copies of unique innovator merchandise, extra research had been wanted for regulatory approval to make sure that variations, if any, didn’t have an effect on affected person security or drug efficacy, significantly since they weren’t generics.
Anurag S. Rathore, Professor Biopharmaceutical Technology, IIT-Delhi mentioned: “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 noticed. “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 within the space of affected person security, mentioned: “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 pressured. “Any slips, in the name of cost-cutting, could prove to be fatal for patients and for the industry,” he added.
