While I Was Away… News On Samsung/Merck; And J&J Remicade® Connections…

We have been following this specific arc of narrative for just over four years now (and the more general S-P Remicade® choke, for going on eight). Whilst we were off grid, our buddy John Carroll very-ably picked up the slack. Do go read all of his, from Friday, past. It is spot-on.

Even so, there is more history to be re-told here. As they say, one’s history is defined by the narrator, after the fact. [We hinted at some of this when we discussed J&J results, last week.]

In this case, the story (in our opinion) starts with less than careful lawyering by the then-GC at legacy Schering-Plough. And it devolves into a multi-billion dollar arbitration with J&J — in the settlement of which, Merck is required to surrender the US rights to Remicade®, to its opponent — J&J. So, when John closes below by saying that Merck will compete in the US against the branded version, while selling its new biosimilar with collaborator Samsung Bioepis — that leaves unsaid WHY that odd state of affairs now exists (with Merck still selling the branded version in Europe). It exists, in my opinion, due to a far too cute attempt to skirt a plainly enforceable contractual provision (which favored J&J/Centocor) — by the lawyers who (last-minute) tried to engineer a more-favorable sale — of legacy Schering Plough — to Merck, in late 2009/early 2010.

. . . .The FDA has approved a new knockoff of J&J’s top earning drug Remicade, which may finally start to shift the market dynamics toward greater competition with lower prices.

This new one is dubbed Renflexis and comes from Samsung Bioepis, one of the big players in the biosimilars field. And it arrives in the US market close to a year after the EMA approved it for Europe.

J&J’s Remicade earned close to $7 billion last year, making this by far its biggest drug in the portfolio. And as J&J noted a few days ago during its Q1 call with analysts, the pharma giant has yet to feel much of an impact from the first Remicade biosimilar from Pfizer, Inflectra (infliximab-dyyb), which was developed by Celltrion and then bagged by the pharma giant in its acquisition of Hospira. That was approved last fall.

Now Merck will pick up the commercialization work of this second knockoff as J&J enters a new stage in defending the huge franchise. Ironically, Merck will now market Remicade in Europe, while competing with it in the US. . . .

But if you’re a regular reader, here — you already well-knew that the irony mentioned above was born in the feverish opium den of drug and biologic non-discovery that was Fred Hassan’s version of Schering-Plough. . . smile.

And so, as we slip into the easy chair in our city-flat, on another languid, clear Sunday night — we will observe that this all unfolded, just as we had predicted — in 2010, 2013, 2014 and 2015. Grin-worthy. Onward. . . as we “wait for sleep to find us” — but tonight, we’ll not need to wait very long, at all [as sometimes it feels like we “write like we are running out of time,” indeed].

नमस्ते

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