Rovi Is Weeks From Long-Acting Risperidone Filing
Long-Acting Letrozole Injectable At Phase I Stage
Rovi hopes by the end of this year to file a hybrid marketing authorization application in Europe for a once-a-month sustained-release injectable formulation of risperidone. A US filing is scheduled for the first half of next year.
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Spain’s Rovi is prioritizing European filing and filling preparations for its long-acting risperidone injectable, pushing back a prospective US regulatory submission until next year.
For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.
In 2019, Mylan moved up to become the world’s leading generics, biosimilars and OTC player, according to Informa Pharma Intelligence’s latest global rankings. Sandoz has surpassed troubled Teva into second place but is set to surrender that position following the sale of its US solid-dose and dermatology business to India’s Aurobindo.