On March 30, the Drug Controller General of India met a dozen-odd industry associations to discuss some new measures, including the critical guidelines on biosimilars. It is an area where differences seem to be emerging between local biotech companies and the global MNCs operating in India. While the domestic biopharmaceutical industry led by Indian biotech major Biocon is appreciating the efforts of the drug controller, some sections of MNCs seem unhappy with both the content and making of the draft guidelines. One of the critical elements in the guidelines that has got the local industry excited is the clause mandating a base number of at least 100 patients for certain clinical trial cases. For the domestic industry this would not only make it relatively easy for them to get the desired number of participants, save costs, without having to undertake certain elaborate, expensive trials and still be able to talk of assuring safety and efficacy.
"From a safety and immunogenicity perspective, if the firm conducts pre-approval studies that included more than 100 patients on the proposed similar biologic drug, the number of patients in phase IV study can be reduced accordingly so that the safety data (from both Phase III and IV) is derived from a minimum of 300 patients treated with the similar biologics," the new guidelines stated, adding: "For a product which is found similar in pre-clinical, in-vitro characterisation having established pharmacokinetics methods and a pharmacodynamics marker that is surrogate of efficacy, the residual risk is significantly reduced in the Phase I study if equivalence is demonstrated for both PK and PD. Phase III clinical trials of such similar biologics product may be waived as noted above or, where considered necessary, an appropriate single arm study in at least 100 evaluable subjects may be carried out in the most sensitive indication to address any residual uncertainty."
However, a section of MNCs seem concerned over "lack of transparency in the whole process of formulating the draft guidelines". Some felt they were not included in the entire process. The Organisation of Pharmaceutical Producers of India was, however, guarded in its response: "We are happy that the government has sought views and we are going to submit a detailed response."
Interestingly, even before the guidelines were issued, India had started approving launch of biosimilar drugs in the country and, currently, there are around eight products in the market - in fact, India has more biosimilars than any other developed country. A lot would now depend on the feedback the drug controller receives within the 30-day window that will shape the final policy. Indian players will be hoping the guidelines are not tinkered with, but given the number of MNCs operating in India, it may not be the case.
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