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Nichi-Iko Looks To File For Interchangeable Infliximab In US Next Year

Executive Summary

With a US filing for interchangeable infliximab scheduled for next year, Nichi-Iko is lining up a launch of etanercept in Japan as it seeks alliances to broaden its biosimilars pipeline.

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Boehringer Settlement Jumps The Queue For Biosimilar Adalimumab

Boehringer Ingelheim has settled litigation with AbbVie over Humira by striking a deal that allows it to launch its biosimilar adalimumab in the US from the start of July 2023.

FDA’s Interchangeability Improvements Impress Industry

Using comparator biologics not licensed in the US is foreseen in final FDA interchangeability guidance, shifting the agency’s previous stance on biosimilars.

Manufacturing Roundup - 19 March 2019

Several firms are looking to expand their manufacturing capabilities through acquisitions and investments; however a number of companies are suffering setbacks. Biocon gets hit with six ‘Form 483’ observations across two sites in India, as Jubilant, Pfizer’s Hospira and Andapharm are slapped with FDA warning letters.

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