The Cross-Border Biotech Blog

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

REMS and Generics — Like Oil and Water

A great post from Michael McCaughan at the In Vivo Blog walks through the very complicated interaction between the world of REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs — and the world of generics.

Under the FDA Amendments Act, which started the whole REMS business, REMS programs aren’t supposed to block or delay generic competition; but it’s not clear the legislators thought this through.  Says Michael:

does FDA really want to make it simple for dozens of sponsors to launch versions of drugs like thalidomide, when the agency has already determined that the risks of inappropriate use are high enough to merit costly, burdensome post-marketing restrictions?

We’ll find out soon… The generics maker Dr. Reddy’s has been unable to obtain any of Celgene’s anti-cancer drug Revlimid to use as a comparator in bioequivalence trials, so they’ve filed a citizen petition with the FDA.  Dr. Reddy’s is proposing mandated access to REMS-covered drugs at market prices for FDA-authorized generics manufacturers.

His bottom line:

Our hunch: products covered by restricted distribution programs will end up looking more like biotech therapies facing follow-on competition than they will like conventional generic drugs.

My bottom line:

If that hunch is right, we’ll know soon enough because innovator pharmas will all be planning REMS generics to go along with their biosimilar plays.

Bookmark and Share

About these ads

One response to “REMS and Generics — Like Oil and Water

  1. Pingback: Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers « The Cross-Border Biotech Blog

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 130 other followers