To improve access to biosimilars for meeting medical needs of the country, guidelines on biosimilars are expected to be released for stakeholder review shortly. The guidelines which were first released in 2012 in consultation with the Central Drugs Standard Control Organisation (CDSCO) and industry are in the process of revision currently.
The guidelines- Guidelines on Similar Biologics, released by the department of biotechnology in 2012 for the first time in June 2012, 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'. These guidelines prescribe the quality, preclinical studies and clinical trial requirements of similar biologics in India.
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.
Says Dr Charu Manaktala, senior director & head of Clinical Strategy, Strategic Drug Development – Asia, Quintiles, "Biosimilars play an important role in the Asian pharmaceutical market. They fill an 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."
Biosimilars in Asia fill an 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.
As far as the pharmaceutical industry is concerned, many Asian companies, especially in India, are experienced in the business of generics. Many companies that have grown primarily on the basis of generics are now looking to diversify into areas with higher risks but also potentially higher returns when compared to traditional generics – and possibly less competition.
"Because the cost of innovator biologics often is very high, they put an extreme strain on healthcare budgets in markets where such therapies are reimbursed. In markets where biologics are not reimbursed, most people are unable to afford these treatment options, which in many cases can be life-saving. These factors create a big gap that copy versions of biologics can fill, Dr Manaktala explains.
Another major reason spurring the biosimilar growth is that patents are expiring by 2020 on biologics worth about $55 billion USD 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.
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.
Because of these factors, many types of companies are joining the biosimilars stampede – traditional big pharma, biotechs, generic players, and new entrants to the biopharma industry, such as Samsung and Fuji Film. Analysts disagree on future size of the market but agree on substantial growth through 2020, with predictions of annual growth rates falling in the 15 to 25 per cent range.
Since the first set of over-arching guidelines for biosimilars were released by the European Medicines Agency in 2005, there has been much development in this space. The US Food and Drug Administration released its first set of draft guidelines in 2012, which have since been finalised. Additional guidelines were released in 2014-15, and others are in the pipeline. US FDA guidelines in the pipeline are expected to cover interchangeability, statistical approaches to evaluation of analytical similarity, and labeling of biosimilars.