Replies to post #100119 on Biotech Values

[DewDiligence]

Is Teva's Rituximab TL011, which is starting nowadays clinical trials, in the regulatory pathway of BLA or as a biosimilar?

It’s a regular BLA.

[DewDiligence]

Re: Patent expirations of biologics

The estimated patent date of Remicade and Rituxan in Europe are 2014 and 2015 respectively. In the US both expiry dates are in 2018. Is this because of Genentech's Cabily patent? If yes, does this mean that the expiry date of most of the mabs in US is 2018?

The answer is unclear because biologics do not have a repository similar to the FDA’s Orange Book to list the patents that confer exclusivity to marketed drugs.

The US healthcare law passed a few months ago establishes an Orange-Book-like mechanism for newly approved biologics (see #msg-48581353, section (8)(H)(3) about 1/3 of the way down), so investors will eventually have a way to answer the kinds of questions you asked without the need for time-consuming research.

[DewDiligence]

Speaking of Remicade…does anyone here care to handicap the upcoming arbitration between MRK and JNJ? The outcome is highly consequential because Remicade is a very big-selling drug outside the US.

I’ve predicted that JNJ will prevail, unless the case is settled prior to a decision by the arbitration panel (#msg-38036981, #msg-41045971).