Docs unsure of biosimilars safety
Some of the drugs have shown adverse indications recently
Safe and effective medication is becoming a major demand as the adverse events of biosimilar drugs such as Razumab, used to treat macular eye degeneration, adalimumab, used for psoriatic arthritis, and erythropoietin HX575 for chronic kidney diseases, have shown adverse sideeffects recorded by various pharmcovigilance committees in hospitals in the country.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an approved biological product; it is also cheaper. The problem with biosimilar drugs is that biologics (biological products) are difficult to replicate and are sensitive to any minute changes in the manufacturing process.
Dr D.S. Ratna Devi, of Indian Alliance of Patients Groups, explains: “Biosimilars have complex molecular combinations and the clinical data collected here in India is only for one disease. In European countries and United States of America they look for more than one disease indication before introducing the product in the market. Hence safety becomes a cause of concern as, other side effects continue to be recorded in the above countries for two years after the drug is introduced in India. This har-ms patients as it adds to their complexities rather than curing them completely.”
Razumab has been used to treat age-related macular degeneration, which causes vision loss in people above 50 years of age. Inflammation has been reported in four batches of the productt and it required steroids to treat the cases.
Due to this reason, ophthalmologists have advised that it not be used till another improved version is available.
Similarly, adalimumab for psoriatic arthritis has registered an event of diarrhoea, upper respiratory tract infection and nasopharyingitis. Erythopoeitin is found to cause pure red cell aplasia, where there is severe anaemia and it requires intensive treatment, but it has not been recorded in all cases and is seen in only a few.
Since clinical trials in India are limited and sometimes controversial, the shortcut methods are causing more damage rather than helping patients.
The various groups who are studying these adverse effects state that there must be a stringent regulatory framework along with proper guidelines before launching biosimilars in the market.
The safety and efficacy of drugs and also longterm adverse effects must be recorded.
The most important point is that patients who suffer from adverse effects must ensure that it is recorded at the hospital level by the pharmacovigilance committee for the larger interests of patients.
BIOLOGICS (biological products) are difficult to replicate and are sensitive to any minute changes in the manufacturing process.