To fast-track approvals of biosimilars or biologics in the country, guidelines on biosimilars are expected to be released soon after a thorough one and half year of consultations with the industry and the Central Drugs Standard Control Organisation (CDSCO).
The guidelines to be released will prescribe the quality, preclinical studies and clinical trial requirements of similar biologics in India. Says Dr G N Singh, Drugs Controller General of India (DCGI), “India specific biosimilars guidelines have been worked out finally in consultation with the industry to make the clearance of biologic products on a fast-track basis because the Indian patients can have access to them. The guidelines would be soon out in a couple of months time.”
The guidelines on similar biologics, released by the department of biotechnology in 2012 for the first time provided requirements for preclinical evaluation of those recombinant products that are claimed to be similar to the already approved biopharmaceutical products, referred as 'similar biologics'.
This comes close on the heels of China FDA releasing its biosimilars guidelines last year which were finalised in March this year.
Biosimilars are copy versions of already approved originator biologics that are marketed after patent expiry for the originator product. The safety and efficacy of the innovator product is already established. Copy versions are allowed to be developed and evaluated using an abbreviated pathway established on biosimilarity principles.
High prices of innovator biologics are straining the healthcare budgets in markets where these medicines are reimbursed. In markets where they are not reimbursed they are unaffordable to most people. As of today, biosimilars in Asia has the potential to fulfil unmet healthcare need and prospects are good from an industry perspective. The availability of more affordable biosimilars options is likely to increase access and open up a new market for these products, and result in better outcomes for patients.
Another major reason spurring the biosimilar growth is that patents are expiring by 2020 on biologics worth about $55 billion in current sales. Whether we take the example of insulins, anti-TNF (Tumour-Necrosis-Factor) biologics or biologics in oncology, these medicines have changed the way many chronic and life-threatening illnesses are treated. These medicines act on very specific targets and, as a result, provide high efficacy with relatively limited toxicity.