This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

FDA Schedules Meeting on Biosimilars

"Interchangeable status" refers to the high regulatory standard by which the biosimilar can be expected to produce the same clinical result as the branded biologic drug being copied.

Without interchangeable status, doctors would have to specifically prescribe the biosimilar drug and switching between the copy and the branded version would not be allowed.

The biotech industry has generally argued against interchangeability because it believes biologic drugs are unique and cannot be copied.

The uniqueness of biologic drugs and the absence of generic competition has been a boon to the biotech industry, which typically charges premium prices for its biologic drugs. The drugs Genzyme makes for the treatment of rare genetic diseases, for example, can cost upwards of $200,000 a year. Treatment with Roche's cancer drug Avastin can cost about $100,000, while Biogen's multiple sclerosis drug Avonex, which patient must take for their entire lives, costs about $20,000 per year.

The eventual approval and launch of biosimilar drugs, therefore is a potential threat to the biotech sector, which could face lower-priced competition for its drugs similar to what has happened to large pharmaceutical companies.

The FDA's public hearing on biosimilars follows the agency's decision in August to approve a biosimilar version of the Sanofi-Aventis (SNY - Get Report) anticoagulant Lovenox developed by Momenta Pharmaceuticals (MNTA - Get Report) and Novartis (TEVA - Get Report).

In Europe, the approval and commercial presence of biosimilars is much further along, although the difficulties and high cost in making biologic drugs has minimized price erosion that usually comes with generic competition.

Among the biologic drugs most susceptible to biosimilar competition include the anemia drugs Epogen and Procrit sold by Amgen and Johnson & Johnson (JNJ - Get Report), respectively, Amgen's rheumatoid arthritis drug Enbrel, Roche's cancer and rheumatoid arthritis drug Rituxan and Biogen multiple sclerosis drug Avonex.

Teva Pharmaceuticals (TEVA - Get Report) has already announced its intention to move aggressively into the market for biosimilar drugs.

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein.

>To submit a news tip, send an email to: tips@thestreet.com.

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
2 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
SYM TRADE IT LAST %CHG
AMGN $164.14 0.10%
BIIB $400.77 -0.06%
JNJ $102.04 -1.50%
MNTA $19.49 1.00%
SNY $50.82 0.14%

Markets

DOW 18,282.20 -3.54 -0.02%
S&P 500 2,130.82 +4.97 0.23%
NASDAQ 5,090.7940 +19.0510 0.38%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs