[Ip-health] Biogenerics to help save nearly $100Bn over 10 yrs

[Sarah Rimmington]

*Biogenerics to help save nearly $100 bn over 10 yrs*
Reghu Balakrishnan
The Financial Express (India)
August 07, 2008
http://www.financialexpress.com/news/Biogenerics-to-help-save-nearly--100-bn-over-10-yrs/345537/#

*Mumbai, Aug 6 - *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."

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/