"Many in the industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully 'substitutable' - which it just has - then this might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing," Tim Anderson, an analyst with Bernstein Research, wrote in a research note on the recent agency action.
Not necessarily.
Remember, the FDA has the authority to use its discretion in asking for new clinical trials for biosimilars and – here’s the sticky question – is Lovenox really a biologic? Sticky question? Not really -- because the answer is, "no."
When it comes to bioequivalence and biosimilars, the FDA will do the right thing.
After all (and with apologies to Senator Kerry), you can’t be for enhanced safety and against it at the same time.
Do not trust all men, but trust men of worth; the former course is silly, the latter a mark of prudence.
-- Democritus
