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pegfilgrastim

Acquisition deal to back European biosimilars market

30 November 2023 | By Catherine Eckford (European Pharmaceutical Review)

Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.

news

CHMP meeting highlights, January 2022

28 January 2022 | By Hannah Balfour (European Pharmaceutical Review)

The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.

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.

news

FDA approves first biosimilar to Neulasta

5 June 2018 | By European Pharmaceutical Review

The U.S. Food and Drug Administration has approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment.

news

Sandoz proposed biosimilar pegfilgrastim accepted by EMA

27 October 2017 | By Dr Zara Kassam (European Pharmaceutical Review)

Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...

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Recommended

pegfilgrastim

Acquisition deal to back European biosimilars market

CHMP meeting highlights, January 2022

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

FDA approves first biosimilar to Neulasta

Sandoz proposed biosimilar pegfilgrastim accepted by EMA