The efforts of Indian biotech firms, which are keen to enter the global biogenerics (copycat version of biotech drugs) market, are boosted by a number of recent studies carried out by various companies and agencies. According to the studies, the availability of biogenerics would save the healthcare system billions of dollars each year. Projecting these studies, the Generic Pharmaceutical Association (GPhA), the largest association for the generic companies across the globe, has highlighted the necessity of more biogeneric drugs in the world.
In its study, Insmed, a US-based biotech company, estimated $67 billion to $108 billion in savings over 10 years, with $236 billion to $378 billion in savings over 20 years for generic versions of the top 12 categories of biologics with patents that either have expired or are soon to expire. A study conducted on behalf of the Pharmaceutical Care Manufacturers Association (PCMA) estimated $14.9 billion in savings over a standard 10-year scoring period for certain biopharmaceuticals in the top 200 Medicare Part B reimbursed categories in the US. And Express Scripts estimated $71 billion in savings over 10 years for products in four therapeutic categories such as interferons, erythropoietin, growth hormone, and insulin.
“For patients facing serious conditions such as cancer and heart disease, safe and affordable biogenerics would allow them to improve their lives while reducing their health care costs,” said Kathleen Jaeger, president and CEO, GPhA. Currently, USA accounts for 55% of the biopharmaceuticals market. By 2010, analysts expect, biologic sales in the US to reach nearly $60 billion and account for a quarter of overall drug sales.
Though the European Medicines Agency (EMEA) has approved the first biosimilar (Sandoz’s Omnitrope in April 2006), the US Food and Drug Administration (FDA) has not approved any. According to Frost & Sullivan, the biosimilar markets in Europe and the US have the potential to generate sales of $16.4 billion by 2011.
Despite the dominance by MNCs in the Indian pharma biotech sector, local firms such as Biocon, Bharat Biotech, Dr Reddy’s Labs, Shantha Biotechnics and Wockhardt have been selling various biotech drugs like streptokinase, human insulin, G CSF, erythropoietin, HGH (human growth hormone) and interferon alpha 2b. Out of 50 recombinant therapeutic products that have been approved globally, around 15 recombinant biotech products have been marketed in the country.
Kiran Mazumdar Shaw, chairman & managing director, Biocon, had told FE, “I believe that biogenerics will command a good market share as healthcare bills are being challenged by mounting costs and need to address affordability through biogenerics. We have developed a pipeline of generic biotech drugs like Insulin, GCSF, EPO, Streptokinase, Glargine etc. and we are already enjoying increased market share in several international markets especially for Insulin. It will be interesting to see how Biotech companies who enjoyed protection from generic competition will respond.”