EMERGING TRENDS IN REGULATORY DEVELOPMENTS FOR BIOSIMILARS: RECENT ADVANCES IN GLOBAL AND INDIAN REGULATIONS

Abstract

Biopharmaceutical drugs have outperformed the pharmaceutical market as a whole largely due to two factors: they address areas of clinical need that are unmanageable with conventional therapeutics (including cancers) and they are able to command a premium price. With expiry of patent of many biopharmaceutical drugs, the potential of a sizeable market will attract several generic companies. However the process to develop essentially generic version of biopharmaceuticals (biosimilars) is more complex than that of developing a generic copy of a chemical-based compound. These products are approved through an abbreviated route which relies on limited safety and efficacy data enabling the generic companies to keep the production costs low and pass on the price benefit to the patient and make the product affordable to the masses. There are no common regulatory pathways and many countries have published guidelines and it is still evolving in other countries. WHO (World Health Organization), Europe and recently USA have published guidelines for the development and marketing of biosimilar products. These products undergo extensive head to head comparability testing with the reference biopharmaceutical product to show their similarity to the reference product in terms of quality, efficacy and safety. Regulators and administrators of different countries need to strike a balance in cost-to-benefit versus risks that are perceived for these products, keeping in mind global regulatory issues. India's biotechnology industry has been growing towards new heights in conjunction with the economic evolution. The practical way forward for approval of biosimilars in India would have to be unique to the Indian context as it should balance the scientific aspects and consider needs and limitation of the country.