Aurobindo Files First Biosimilar In Europe With Pegfilgrastim
Indian Giant’s CuraTeQ Subsidiary Files BP14 Neulasta Rival With EMA
Aurobindo has submitted its first biosimilar application to the EMA, with the Indian company’s CuraTeQ subsidiary filing its BP14 pegfilgrastim rival to Neulasta.
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Aurobindo’s CuraTeQ has withdrawn EMA filings for its filgrastim and pegfilgrastim biosimilars over inspection timing issues – but expects to refile the products as it works towards obtaining the necessary EU GMP certification.
Aurobindo is looking to grow its business in India by acquiring Veritaz’s domestic formulations operations in a $22.4m slump sale.
Aurobindo will formalize a succession plan in early December as managing director N Govindarajan, who has spent over a decade at the company, is set to move on. Meanwhile, though a settlement has been reached for generic Revlimid launch plans, development of a COVID-19 vaccine with partner Vaxxinity has hit a major roadblock.