MEDtalks with Dr KK Aggarwal
In Delhi we have now two government bone banks, at AIIMS and GTB hospital. Bone banks collect grafts from cadaver donors. These are used for reconstruction of large bone defects. Unlike the heart and the kidneys that must harvested within 6-8 hours of brain death, bones can be removed within 24 hours, and preserved for more than 20 years at -80 degrees Celsius. One bone graft can be used to treat more than 15 persons.
At Ganga Ram hospital another bank is currently using well processed and gamma irradiated cortico cancellous bone allografts from tibial slices and femoral heads, bones from amputated stumps in various clinical conditions. The grafts are screened for HIV, HCV, HBV and syphilis to eliminate risk of disease transmission. Unlike other transplants, bone graft recipients do not have to take any immunosuppressant or other drugs. They preserve the graft for a year.
A “biosimilar” is defined by the World Health Organization as a “biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product” and the “similarity” is defined as the “absence of a relevant difference in the parameter of interest.” The biosimilar agents are expected to be marketed at a lower cost than the original biologic medications.
Biosimilars are not the same as generics. A generic drug is an identical copy of a currently licenced pharmaceutical product that has an expired patent protection and must contain the ‘same active ingredients as the original formulation’. A biosimilar is a different product with a similar, but not identical, structure that elicits a similar clinical response. As a result, biosimilars medicines have the potential to cause an unwanted immune response. Whereas generics are interchangeable, biosimilars are not.
The potentially lower cost of biosimilars raises the risk that insurers may favor them over the original reference medicine, even when they may not be appropriate for an individual patient. India must cultivate national guidance on safety of biosimilars.
India (CDSCO) Definition: Similar biologics- A biological product/ drug produced by genetic engineering techniques and claimed to be “similar” in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India by DCGI based on a complete dossier, and with a history of safe use in India. In 2012, India has issued the Similar Biologics Guideline by Central Drugs Standard Control Organization and the Department of Biotechnology.