InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,477.90
(
0.16%
)
US TECH 100
19,129.60
(
-0.24%
)
Dow Jones
39,127.80
(
0.04%
)
Brent Oil
84.15
(
-0.38%
)
Bitcoin
61,050.33
(
0.39%
)
Post# of 19309
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Replies (2) Keep Next 10 Report Keyboard Shortcuts
Replies (2) Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 833
Posts 119931
Boards Moderated 17
Alias Born 09/05/2002

DewDiligence

Member Level

Re: None

Friday, 06/22/2007 9:55:52 AM

Friday, June 22, 2007 9:55:52 AM

Post# of 19309
Europe’s CMHP Approves Three More Biosimilar Drugs

[The drugs in question are knockoffs of Epogen/Eprex, whose European patent has expired.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070622:MTFH17234_2...

>>
Fri Jun 22, 2007 9:42 AM ET
By Ben Hirschler, European Pharmaceuticals Correspondent

LONDON, June 22 (Reuters) - Europe accelerated its adoption of so-called biosimilar medicines on Friday as an expert panel recommended the approval of three cut-price versions of epoetin alfa, or EPO, for treating anaemia.

The London-based European Medicines Agency (EMEA) gave a green light to Binocrit from Sandoz and Epoetin alfa from Hexal, both units of Novartis AG, and to Abseamed from Medice Arzneimittel Puetter.

All three products were deemed similar to Johnson & Johnson's <JNJ> Eprex -- given to some cancer patients and people with chronic kidney disease -- which was the reference product for the agency review.

The arrival of biosimilars marks a watershed for the biotechnology industry, which until now has almost never faced generic competition for its products, even after patents expire. Their entry is being fiercely resisted by some biotech firms.

With prices expected to be 25 to 40 percent below those of original brands, biosimilar drugs could save governments billions of euros a year, according to European Generic Medicines Association.

Europe has been quicker to allow such products on to the market than the United States, although Democratic lawmakers there are fighting to clear the way for cheaper versions of pricey biotech therapies.

European regulators had previously backed two biosimilar growth hormone drugs but the latest recommendation opens up a much larger opportunity, with EPO medicines selling billions of dollars a year worldwide.

EMEA head Thomas Lonngren told Reuters in an interview in March the pace of applications for biosimilars from generic drugmakers had picked up and more approvals could be expected from the agency this year.

Andreas Rummelt, CEO of Sandoz, the generics arm of Swiss-based Novartis, said European approval would offer patients and healthcare payers a high quality, cost-effective alternative to branded epoetin alfa treatments.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months.

For the generics industry, biosimilars are an enticing prospect. Because they are manufactured by biotechnology methods and are complex protein molecules derived from living organisms, they command a better price than conventional chemical drugs. But the complicated manufacturing process also makes them controversial, since small variations in the procedure means they will never be exact copies of the original branded drug.

Rummelt said Sandoz was determined to be a leader in the field.

"We are committed to further developing these types of medicines and have several projects in the pipeline," he said, adding that the loss of patent protection on more biotech drugs in coming years would expand the market.

Other big generic drugmakers -- in Europe, the United States and India -- are also eyeing the opportunity eagerly.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Replies (2) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (2) Next 10 Prev Next

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up