Hyderabad: With 15 more biosimilars set to enter the Indian market by the year-end, the World Medical Association has asked the Indian Medical Association to draw up proper guidelines for their use, effectiveness of treatment and safety of patients.
Biosimilar drugs are used for challenging diseases like rheumatoid arthritis, Crohn’s disease and cancers. Biologics are the original drugs made from living cells and are patented. Biosimilars are the generic version of the small molecules of drugs. Their process of development is not like that of generic drugs.
Dr K.K. Aggarwal, senior member of the Indian Medical Association, explained, “Biosimilars are not like generic drugs and the patient’s condition has to be evaluated properly before are used. Hence it requires the drug controller and the IMA to clear for whom they are is to be prescribed.”
He said if the original biological drug costs Rs 1 lakh and the biosimilar costs Rs 30,000, it is important to understand the difference between the two.
“This is now being stressed by the WMA as many more drugs whose patents are expiring will make their way to India. This requires physicians and drug controllers to have clarity on their use on the type of patients and their safety and effectiveness.”
The WMA has stressed that when the first line of medicines is working on the patient with challenging diseases, it is important to continue treatment and not push biosimilar drugs because they are available. They have to be used sparingly on patients who need biosimilars, and whose response to the standard procedures of treatment is not as required.
According to Dr K. Soma Sekhar Rao, consultant medical gastroenterologist and hepatologist from Apollo Hospitals, biological drugs and biosimilars can have multiple and serious side-effects which require to be evaluated before they are put to use.
“With the prevalence of tuberculosis and chronic infections in India, the risk factors are high. This makes it difficult to evaluate whether the treatment is effective. Hence biosimilars must be used judiciously,” Dr Soma Sekhar Rao said.
Dr Padmaja Lokireddy, consultant haemato-oncologist and stem cell transplant expert, said, “Until and unless there is good evidence that a biosimilar will give better results than traditional medicines, it must not be used. There is misuse of biosimilars due to excessive marketing and emphasis on new medicines.”
Dr Vijay Anand Reddy, senior cancer specialist, said, “Biosimilar drugs like any other drug are found to work differently on different patients. The local biosimilars have shown good results in the case of some tumours and average results in others. Hence it is very difficult for a physician to guarantee a result.”
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