With the suspension of the registration of 36 similar bio-therapeutic products in Sri Lanka, the country's healthcare market has become an open ground for the monopoly of biologics originators. Sri Lanka's regulatory agency blacklisted and suspended sale of some bio-therapeutics products being imported from six countries after concerns over their efficacy and safety.

In 2011, the biologics market in Sri Lanka was estimated to be around eight-to-10 percent of $444 million pharmaceutical market. With rise in chronic and lifestyle diseases, the market for biologics has been increasing in Sri Lanka in the last many years.

With the immediate suspension order, patients using insulin, insulin analogues, erythropoitins, filgrastim, interferons, low molecular weight heparins, growth hormones, somatotropins, hypothalamic and pitutary hormones, hepatitis B vaccines and monoclonal antibodies for last five-to-six years will be forced to pay more for the originator drugs.

Nine companies in Sri Lanka, which were importing similar bio-therapeutic products from 19 companies in India, China, Korea, Pakistan, Argentina and Mexico have to wait for at least three-to-four months to re-launch the products in the local market. ABC Pharma services and Emerchemie NB (Ceylon) led the table with the import of 10 similar bio-therapeutic products each, followed by Hemas Pharmaceuticals with six similar bio-therapeutic products. ABC Pharma, established in 1999, is the leading importer and distributor of a wide range of pharmaceutical, healthcare and biotechnology products in Sri Lanka, representing some of the world's leading pharmaceutical and biotechnology companies. Emerchemie NB (Ceylon) too emerged as the third largest pharmaceutical agency house in Sri Lanka within a short span of 10 years. It has over 350 employees. Hemas Pharmaceuticals is the country's largest pharmaceutical distributor with a workforce of over 600 employees.

Welcoming the government's decision of suspension, Mr Adrian Basnayake, managing director, ABC Pharma Services, says, "Although some biosimilar enoxaparin, interferon, somatotropins and insulins have been in the Sri Lanka market for over 10 years in some instances, greater regulatory scrutiny of the biosimilars is welcome especially in the light that many unknown sources from China and India have entered this market segment. Both the sources have a history of quality failures for pharmaceuticals. Biosimilars are often used in seriously ill patients. Hence, there is a greater need to demonstrate efficacy and safety of these rather than in products for some chronic illness, such as hypertension or hypercholesterolemia."