Biosimilars products are medicines similar to already patented or registered biotech products, but are manufactured by new companies after the patent expiry of the originator product, sometimes also referred as ‘follow-on' biologics. Biosimilars of top selling products such as Humira, Enbrel, Rituxan/ MabThera, Avastin, Herceptin and Remicade are going to hit market very soon. Infliximab biosimilar (Celltrion) is already approved and marketed in the European Union, and Etanercept biosimilar (Samsung) has received approval from the EMA’s Committee for medicinal products for human use & will also be launched soon. Current global biosimilars market according to July 2015 report of ‘Markets and Markets (M&M)’ is expected to grow to US$ 6.22 billion by 2020 from US$ 2.29 billion in 2015 and will grow at a CAGR of 22.1 per cent from 2015 to 2020.

Over the last several years, Asia has been emerging as the promising destinations for international outsourcing of biopharmaceutical manufacturing. In the recent times, India and China both are reportedly showing promises to become the industry’s top potential destinations for off shoring over the next five years, ahead of traditional bio manufacturing hubs in the US and Western Europe. Indian biosimilars industry was US$ 338 million in 2008 and was growing at 30 per cent. Currently, more than 50 biosimilar products are now available in the Indian market and crossing sales of US$ 900 million. Over 10 pharma players are competing in this area with around 15 epoetin, 8 G-CSF and four insulin biosimilars, besides a few others.

The first biosimilar of the world’s top-selling medicine Humira (adalimumab) of AbbVie was launched in India by Zydus Cadila. EvaluatePharma also forecasts that Humira of AbbVie would continue to remain the bestselling drug of the world at least till 2018 with sales of US$12.8 billion, despite its US patent expiry in 2016. Moreover, to succeed Humira that will go off patent between end 2016 and 2018 (Europe), AbbVie reportedly has seven new drugs in clinical development for Rheumatoid Arthritis. These patented new drugs could also significantly cannibalize the sales of Humira.

Asian manufacturers have been successful so far to approvals in the EU. With this trend we can expect Asian players to establish in western markets. There are significant numbers of players from China, India and Korea who are exploring opportunities in Asian market as well as global market. China FDA recently released biosimilars guidelines. India announced the release of draft regulatory guidelines for ‘similar biologics’ at the BIO industry conference in Boston, USA, on June 19, 2012. Finalized guidelines were implemented on September 15 , 2012. The guidelines outline a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years. The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT – under the Ministry of Science and Technology), through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO – under the Ministry of Health and Family Welfare).

The European Medicines Agency (EMA) has approved biosimilars for somatropin, epoetin, filgrastim, follitropin, insulin glargine and infliximab in the last 10 years. A biosimilar for etanercept has also received approval from the EMA’s Committee for Medicinal Products for Human Use last year. As of now, enoxaparin, infliximab, etanercept, rituximab and pegfilgrastim biosimilars are under evaluation in the European Union.

Significant progress has been made in the past few years with European Medical Agency (EMA) leading the way, when it developed and issued comprehensive guidelines for licensing of biosimilars in 2005. EMA followed an extensive and broad-based process that involved seeking opinion from multiple stakeholders (including scientists, regulators, physicians, patient groups, general public, others). These guidelines have enabled 14 biosimilars to be approved in the EU so far. Subsequently, similar guidelines have come into force in various countries across the globe.

Countries from Asia such as South Korea, Malaysia, Taiwan, Turkey, Sri Lanka and Japan which have enforced national guidelines which are adopted from European guidelines. In 2009, World Health Organization (WHO) issued guidelines to provide globally acceptable principles for licensing biotherapeutic products that claim to be similar to approved reference biotherapeutic product (RBP). These guidelines can be adopted by National Regulatory Agencies (NRA) worldwide for establishing national regulatory frameworks for licensure of biotherapeutic products.

Biosimilars were flooding the global market and considered as value driving factors for the important markets such as, Europe, Australia and India but United States approved its first biosimilar ‘’Zarxio‘’  in the  in March 2015. It is a biosimilar version of filgrastim manufactured by Sandoz. Sandoz’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen. Though such types of drugs are available in markets like Europe, Australia and India, the launch of Zarxio heralds the dawn of a new era of biosimilar drugs in the United States.

According to Express Scripts report released in December 2014, the US healthcare system could clock savings in drug costs around US$ 250 billion in the first decade of availability of biosimilars drugs and the approval of Zarxio would help patients saving more than US$5 billion in the the world’s largest market for biologics. However, success depends on the prescriptions achieved, unlike generics or branded generics selling biosimilars is not that easy.

Applications under assessment in the US include Sandoz’s etanercept biosimilar (October 2015), Sandoz’s pegfilgrastim biosimilar (November 2015), and Amgen’s adalimumab biosimilar (Nov 2015). Approvals of more biosimilars for anti-TNF biologics, as well as biosimilars for oncology products, are expected in 2016.

Major growth drivers which again going to remain same for next few years are high prevalence of chronic disease across the globe, growing pressure to reduce healthcare expenditure, favourable intervention from developing economies & market opportunity as many blockbuster biologics are going off patent. Along with the opportunities that are present in the market, there are some restraints. Out of that pricing is most important.

Initially when biosimilars were launched in the European Union, they were priced at a 20 to 30 per cent discount to the branded product, to start with. As the market progressed, innovators are dropping their prices in order to retain their market share, and biosimilar manufacturers are dropping their prices even further with discounts reaching as deep as 70 per cent of the innovator’s price in some cases.  Even in developing countries of Asia , price of the biosimilars can further forced to reduce by one tenth of the original biologic drug. Other restrains are high investments in setting up manufacturing facilities as well as for research and development, stringent regulations in developed economies, medical efficacy and patient safety.

Asia has the huge potential to lead in the development and manufacture of biosimilars, not only to serve the needs of the local population but also for export to large developed markets. India can become one of the major players in biosimilars globally. However, for this India needs guidelines, that should provide an abbreviated regulatory framework that ensures that such products approved in India are of good quality and demonstrated to be biosimilar in efficacy, safety and immunogenicity to the original reference products. The need for such a regulatory framework and guidelines is even greater in light of the current suboptimal pharmacovigilance system in India and in process to match standards of global level.

Considerable developments have occurred across the globe, in the scientific and regulatory understanding of biosimilars. Nearly all developed nations and several of the developing countries have now defined appropriate regulatory framework, drawing heavily from EMEA guidelines and adapting in parts for local scenario. More recently approved WHO guidelines further provide a good basis for developing countries to draw upon and adapt.

Currently due to the lack of such a definition in India, there are so-called “biosimilar’ drugs which are being approved with sub-optimal testing and dossiers, thereby putting into question product quality, comparability and patient safety. In view of this there is an urgent need for the Indian government to formulate guidelines for the regulatory approval of biosimilars. These guidelines must address the key scientific considerations highlighted above given the complexity and inherent heterogeneity of biologic drugs. This will be a crucial step for ensuring safety, quality and efficacy of more affordable biosimilar drugs available to patients in India and across the globe.