Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.
The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.
- read the analysis [1] in the RPM Report
Related Articles:
Budget has mandate for biogeneric approvals [2]
Waiting game continues for biogenerics [3]
Dr. Reddy's make risky biogenerics move [4]
Lawmakers propose pathway for approving biosimilars [5]
Links:
[1] http://therpmreport.com/EMS_Base/Agent.aspx?Page=/Content/2008500050.aspx?offer=30DayTrial_SB
[2] http://www.fiercebiotech.com/story/budget-has-mandate-biogeneric-approvals/2008-02-05?utm_medium=rss&utm_source=biotech_Generics
[3] http://www.fiercebiotech.com/story/waiting-game-continues-biogenerics/2007-09-10
[4] http://www.fiercebiotech.com/node/7447
[5] http://www.fiercebiotech.com/story/lawmakers-propose-pathway-for-approving-biosimilars/2007-02-15