January 19, 2011
Posted by on
In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.
The biosimilars market has also evolved in a couple of unexpected ways:
- Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
- At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”
As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.
This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.
February 2, 2010
Posted by on
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.