Sandoz Pushes Back Pegfilgrastim U.S. Resubmission Target Date

Biosimilar News

Novartis recently released its Q2 2017 financials, which included updates on various biosimilar products in its subsidiary Sandoz’s pipeline.

Pegfligrastim

As we previously reported last July, the FDA last year issued a complete response letter (CRL) rejecting Sandoz’s aBLA for LA-EP2006, a proposed biosimilar of Neulasta® (pegfilgrastim).  Sandoz subsequently indicated that it was conducting an additional PK study in response to the CRL and reported in January that it was on track to resubmit the application to FDA in 2018.  In April, Dr. Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis, told investors on the Q1 2017 earnings call that “we continue to be on track as well with our pegfilgrastim filing, which we expect to happen in the first part of 2018.”

Earlier this month, Novartis announced as part of its Q2 2017 financial results that its target for resubmitting its pegfilgrastim application has been pushed back from 2018 to the first half of 2019. See slides 38 and 42.  Dr. Narasimhan explained to investors on the company’s Q2 2017 earnings call:  “We are on track to – in addition to file pegfilgrastim in the EU and the second half of 2017, we have shifted the date of our pegfilgrastim filing in the U.S. by a quarter to early 2019 in order to accommodate a change in the study design.”

Epoetin Alfa

The current status of HX575, Sandoz’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), is unclear.

Last year, Novartis indicated that it was planning to submit an application in the U.S. for this product in 2016. See Q3 2016 presentation slides 43 and 50.  This past April, Novartis indicated that it was targeting a U.S. submission in 2017 for this product. See Q1 2017 presentation slide 44.  When asked about the delay in the U.S. filing for this product on the April earnings call, Dr. Narasimhan told investors:  “With respect to Epo[gen], we’re continuing to evaluate some additional data that has come in, and then once we fully evaluate that data, we’ll clarify our filing strategy on Epo[gen].”

In its Q2 2017 earnings presentation this month, however, Novartis omitted any mention of HX575 and did not address the status of this product during the call with investors. See slides 38 and 42.

Adalimumab

In January, Novartis reported that it had pushed the anticipated FDA filing date for its adalimumab biosimilar candidate, GP2017, back from Q4 2016 to the first half of 2017.  In April, Novartis indicated that it was targeting a submission date in the second half of 2017. See slides 40 and 44.  During this month’s Q2 2017 earnings call, Novartis reported that it was still “on track to file adalimumab in the U.S. in 2017, in the second half.” See slides 38 and 42.

Rituximab

Novartis’s Q2 2017 earnings presentation indicated that Sandoz is still on track to file an application with FDA in the second half of this year for GP2013, its proposed biosimilar of Rituxan® (rituximab). See slides 38 and 42.

Stay tuned to Big Molecule Watch for further updates.

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