The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Biotech Trends Update: Teva’s BLA for Neupoval is Accepted at the FDA

Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today.  Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of Teva’s clinical data and potentially for approval of the product.

FDA approval isn’t Teva’s only hurdle, though.  Amgen’s U.S. patents on Neupogen don’t expire until 2013, and the two companies are currently litigating the issue of whether Teva’s product infringes those patents.  Furthermore, the Dow Jones article quotes Credit Suisse analyst Michael Aberman who points out that in the EU Teva’s product only has 5% market share, competing against both the original Neupogen and Amgen’s longer-acting Neulasta.

Investors’ reaction? Teva shares were up 1.4 percent, Amgen shares were off minutely.

My bottom line: If you want to read tea-leaves to predict the approach other biosimilar products will take (and I do), watch the Neupoval BLA closely.  The calculus undertaken by other potential market entrants will weigh Teva’s success and costs with this approach against the costs of any Congressional requirement for data exclusivity period and any FDA requirement for clinical trials in an eventual biosimilars regime.

Follow our coverage of North American biosimilars news on this Biotech Trends in 2010 page.

Bookmark and Share

About these ads

4 responses to “Biotech Trends Update: Teva’s BLA for Neupoval is Accepted at the FDA

  1. Pingback: Biotech Trends Update — Biosimilars: FDA Meeting Formally Announced, EMA Working on Rules for (a few) Antibody Biosimilars | The Cross-Border Biotech Blog

  2. Pingback: EMA Working on Rules for (a few) Antibody Biosimilars « The RIC Blog

  3. Pingback: Biotech Trends Update — Biosimilars Blur IP Constituencies: Novartis and Pfizer-Biocon are Featured in the Economist | The Cross-Border Biotech Blog

  4. Pingback: Biotech Trends in 2011: Biosimilars « The Cross-Border Biotech Blog

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 129 other followers