FDA approves second biosimilar; Copaxone copy Glatopa launch pending, uncertain

Well, we now have two biosimilars approved in the US with the FDA’s marketing approval of Sandoz / Momenta’s copycat version of Copaxone for relapsing-forms of multiple sclerosis (RRMS), a chronic disease of the central nervous system characterized by inflammation and neurodegeneration.

 Glatopa (which sounds like something ESH’s parents left behind in stari kraj) will be the real game changer in the world of biosimilars. Maybe.

The first biosimilar approved (also from Sandoz…..  a copy of Amgen’s Neupogen) doesn’t and won’t have the same market-changing impact in a well-defined therapeutic category like MS – so this would be the one to watch, ESH thinks.

Çekaj!  TEVA, the Israeli firm which is very steamed up about this copycat stealing their market share, is still likely to find yet more roadblocks to keep Glatopa off the market (even the US Supreme Court refused to stop Sandoz) – at least for a short while.

We know that the ‘naming’ convention issue has not yet been settled with the FDA.  So will the package insert say the same as Copaxone – glatiramer acetate injection? Curious minds want to know!   And, the regulations related to ‘interchangeability’ have  yet to be issued by the FDA.

So, will Glatopa be listed as an A/B rated product? Or some other designation?  In the article here there is a clear reference to being fully substitutable at the pharmacy level. (Remains to be seen.)

Also, what about all those states (we know the Kenyan kommie thinks there are 57) that have a say in pharmacy regulations and some even have legislation already passed making biosimilar launches very difficult  as we have covered in earlier alerts.

Another important point from reimbursement standpoint and economic impact to health plans and governmental payers: the cost for Glatopa  has not been released (that’s no surprise….   Sandoz still has to factor in all their legal expenses and other A&O costs to get this product to market).

That may be one of the most interesting elements of this journey to the biosimilar side.