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Celltrion

Two novel biosimilars approved in EU and US

29 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.

article

Moving towards oral delivery of biologics

22 February 2023 | By Talat Imran (Rani Therapeutics)

In this article, EPR’s Caroline Peachey speaks to Talat Imran, CEO of Rani Therapeutics, about progress towards oral delivery of biologics using robotic capsules.

news

EMA COVID-19 treatment evaluations update

26 February 2021 | By Hannah Balfour (European Pharmaceutical Review)

The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).

article

Five patent issues that European biosimilar developers should consider before entering the US market

26 June 2020 | By Grace Truong (Goodwin Procter LLP), Joshua Whitehill (Goodwin Procter LLP), Natasha Daughtrey (Goodwin Procter LLP)

As patents on originator biologic medicines begin to expire, there are growing opportunities for biosimilars to enter the market at lower prices. Joshua Whitehill, Natasha Daughtrey and Grace Truong discuss key aspects of US patent law that European developers should consider before entering the American market.

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