Replies to post #74268 on Biotech Values

[WID]

Dew,

I just want to know what is your sentiment or perception on MNTA? This stock has been falling back to close to its 52-week low.

Are your still keeping the same sentiment?

Thanks!
WID

[tony111]

I don't see why biologics get only 5 years of exclusivity like small molecules when the cost of bringing a biologic to the market is much more expensive than that of a small molecule.

[genisi]

All signs show that this is going toward a compromise. Note that Waxman has proposed a similar legislation in 2008 with no period of exclusivity at all. Also there are some other bills and even if the main proposals of Waxman will dominant the final law, I believe exclusivity will likely be higher than 5 years.

[Biopharm investor]

Generic biologics bill introduced in US

US lawmakers introduced legislation on Wednesday that would create a pathway for approval of generic formulations of biotechnology drugs that is closer to that which is in place for chemical compounds.

Under the proposal, companies would be allowed to manufacture biogeneric or biosimilar versions of a brand-name biotech product after it has been on the market for five years, rather than the 14 years advocated by certain companies in the biotechnology industry. The legislation would also allow the FDA to determine what studies are needed to determine whether a generic biologic drug is as safe and effective as the original product, and to decide if the formulations are interchangeable with the brand-name drug.

Sanford C. Bernstein analyst Ronny Gal has forecast that sales from biosimilars in the US may range from $4.9 billion to $12.6 billion in 2015.

Source: FirstWord

[north40000]

Some more color on Waxman et al legislative proposal:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/03/rep-waxman-introduces-followon-biologics-bill-legislation-hews-closely-to-hatchwaxman-exclusivity-pa.html