Richter shares dive after application withdrawal


Image by

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 company始s website.

According to the announcement, the MAA filing was based on comparative quality, non-clinical and clinical data from the company始s 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 company始s 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 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.


PMI Falls to 55 Points Figures

PMI Falls to 55 Points

Gov't Guarantees on Liabilities Climb Over 9%聽of GDP in 2021 Government

Gov't Guarantees on Liabilities Climb Over 9%聽of GDP in 2021

OXO Technologies Looks for New HQ Elsewhere in EU Innovation

OXO Technologies Looks for New HQ Elsewhere in EU

Hungary Adopting Performance-based Financing for Arts Art

Hungary Adopting Performance-based Financing for Arts


Producing journalism that is worthy of the name is a costly business. For 27 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.
Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.