Eva von Schaper and Naomi Kresge, writing for Bloomberg overnight, have a story out about the much anticipated EU draft regulations that will govern the process for seeking approval to sell “generic” versions of bioscience therapies generally, and monoclonal antibodies, specifically, once patent protection ends.
These, as many may know, aren’t really “generics” in the traditional sense — they will be biologically-similar to the original, but will not be simple, exact chemical copies of the same protiens, etc. The reasons for the difference are manifold, but suffice it to say that manufacturing a powder pill or capsule is a very different process than extracting monoclonal antibodies.
Still, the market potential here is vast, and growing — with some of the earliest biotech therapies coming off patent in Europe (and the US) the next few years — Teva and others will be looking to sell unbranded, but similar versions of these complex protiens and other bioagents.
Interestingly, Remicade® is among those due to lose patent protection before 2015, making the arbitration story just a little more complicated. If Merck wins the arbitration, it and J&J’s Centocor unit will share equally in the loss of revenue on Remicade — 50-50, by then — throughout the EU zone. If Merck loses the overall $10 billion arbitration, it will lose all the Remicade (and Simponi®) sales revenue next year. Then, sometime in 2015, J&J will begin to see sales erosion in the EU due to biosimilar competition, likely from Teva.
. . . .Europe’s drug regulator set out guidelines for copying some of the most expensive biotechnology medicines, giving companies such as Novartis AG and Teva Pharmaceutical Industries Ltd. access to a $36.4 billion market.
The European Medicines Agency’s draft regulation, posted today on the agency’s website, aims to clarify how drugmakers can copy and sell so-called monoclonal antibodies after they lose patent protection. The document is open to public comments until May 31, the London-based agency said. . . .
We’ll keep you informed about the emerging path of the law, here — as it portends to redefine a $50 billion market landscape for such therapies. [Addendum — here is the 11 page PDF file of the draft regs for clinical in vivo use of monoclonal antibodies.]