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Richter shares dive after application withdrawal

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Image by Richter.hu

Shares of Hungarian pharmaceuticals maker Gedeon Richter fell 1.2% by 4 pm Monday after the company announced the withdrawal of its marketing authorization application (MAA) for biosimilar pegfilgrastim from the European Medicines Agency (EMA), according to an announcement on the companyʼs website.

According to the announcement, the MAA filing was based on comparative quality, non-clinical and clinical data from the companyʼs completed biosimilar development program. During the November 2016 meeting of the Committee for Medicinal Products for Human Use (CHMP), the committee indicated that the data provided did not allow it to conclude a positive benefit risk assessment.

The companyʼs management is committed to continue the clinical development and regulatory process of pegfilgrastim in order to eliminate the remaining uncertainties identified by the CHMP during the review process, said the Richter announcement.

Richter told online economic news portal portfolio.hu that it plans to re-submit its application for pegfilgrastim in the first half of 2018. Thus far, the report added, Richter has spent a total of EUR 45 million on development, and following the withdrawal further clinical tests are expected to consume another EUR 10 million.

According to Richter, a biosimilar medicine is a biological medicine that is developed to be highly similar to an already authorized biological medicine (the "reference medicine"). Pegfilgrastim, which is used for cancer patients to help with some of the side-effects of their treatment, is expected to be introduced on the market in mid-2019.

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