Wednesday, September 07, 2016 9:00:34 AM
Analyst Jason McCarthy commented:
With Teva (TEVA-$51.33-Buy) markedly reducing the Copaxone opportunity through years of patent litigation, Momenta shifted focus towards biosimilars, particularly a biosimilar of Humira, which we believe was a goal outside the reach of the company, even with Baxalta (Shire) as a partner. Recall that Baxalta walked away from developing additional early stage biosimilars with Momenta, which were subsequently partnered to Mylan.
The race for biosimilar Humira could come down to IP. Dosing and formulation patents represent significant hurdles that could delay commercialization of Humira biosimilars for several companies, we believe, including Momenta and Amgen, until at least 2022. More specifically, we are referring to Humira patents protecting dosing ('135) and formulation ('157 and '158).
Amgen was already denied Inter-Partes Review (IPR) for '135. In addition, to our knowledge, Momenta and Amgen both use stabilizing agents called "surfactants" and "polyols" in their biosimilar formulations, which could infringe on AbbVie '157 and '158, two key patents that do not expire until 2022.
The only biosimilar player we are aware of that specifically developed a biosimilar for Humira with a strong focus on IP is Coherus Biosciences (CHRS - $30.03 - Buy). Coherus won IPR vs. AbbVie '135 and has patent-protected formulations that may not infringe on AbbVie '157 or '158, positioning a potential commercial launch in 2019, in our view.
Nothing about 40 mg copaxone in here
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