The Cross-Border Biotech Blog

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

Tag Archives: BLA

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.

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Teva Decides Not to Wait for U.S. Biosimilars Legislation

In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.

Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their joint venture with Lonza means their technical capabilities will only increase).

Yesterday, Teva announced that they were not waiting for a Biosimilars regime to be enacted before entering the U.S. market, and instead will take on the extra cost of filing a full BLA for their version of the biologic.

Does this mean we don’t need a biosimilars regime to get biosimilars to market?  Teva itself takes a different position.

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