Momenta Pharmaceuticals, Inc. (MNTA)

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New pre grant patent application,

METHODS RELATED TO BIOLOGICS

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PG01&s1=momenta&OS=momenta&RS=momenta

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[0030] Detailed, high resolution, physiochemical and/or structural information about Actemra.RTM. (e.g., related to the presence of signature glycan species or quantitative analyses ascribing site-specificity for backbone modifications) can be used in the manufacture of products that qualify as tocilizumab, e.g., that are interchangeable versions of Actemra.RTM.. Such information is also useful in monitoring product changes and controlling structural drift that may occur as a result of manufacturing changes. One exemplary report states that "[t]he size and complexity of . . . therapeutic proteins make the production of an exact replica almost impossible; therefore, there are no true generic forms of these proteins . . . . Verification of the similarity of biosimilars to innovator medicines remains a key challenge." (Hincal et al "An Introduction To Safety Issues In Biosimilars/Follow-On Biopharmaceuticals", J. Med. CBR Def, 7:1-18, (2009)). This disclosure provides, in part, methods and compositions sufficient to make and test products that qualify as tocilizumab, e.g., that are interchangeable versions of Actemra.RTM.. “

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