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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

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) anticoagulant Lovenox developed by Momenta Pharmaceuticals (MNTA) and Novartis (TEVA).

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), respectively, Amgen's rheumatoid arthritis drug Enbrel, Roche's cancer and rheumatoid arthritis drug Rituxan and Biogen multiple sclerosis drug Avonex.

Teva Pharmaceuticals (TEVA) 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

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,943.81 +28.74 0.17%
S&P 500 1,967.57 +2.89 0.15%
NASDAQ 4,415.49 +19.2860 0.44%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs