Roche Sues Amgen Over Avastin Biosimilar (AMGN)

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Roche Sues Amgen Over Avastin Biosimilar (AMGN)
Genentech, a unit of pharmaceutical giant Roche AG (RHHBY), filed a lawsuit claiming Amgen Inc. (AMGN) withheld key information about its proposed biosimilar of Genentech’s cancer drug Avastin
that could potentially spur patent infringement litigation.
Genentech wants the court to compel Amgen to provides all the necessary data Genentech needs, as well as allow Genentech’s expert assessment,
and put forth new deadlines for resolving any possible disputes arising from patent infringements.
BPCIA rules require that a new applicant should provide “information
that describes the process or processes used to manufacture the biological product.”
Genentech claims Amgen only submitted its application and did not provide FDA-required details.
Under the Biologics Price Competition and Innovation Act (BPCIA), the originator, Genentech,
has 60 days for expert review and claim for any possible patent infringements.
It was first approved in February 2004, and has since then secured nine different approvals from the Food
And Drug Administration (FDA) to treat colorectal, breast, lung, kidney, cervical and ovarian cancer.
The filing cited Amgen’s attempts to block a biosimilar rival of its anemia drug Epogen, when Amgen
sued Hospira Inc., which is owned by Pfizer Inc. (PFE), for non-compliance with the BPCIA.

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