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CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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Acquisition deal to back European biosimilars market
Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.
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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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Five patent issues that European biosimilar developers should consider before entering the US market
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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FDA approves first biosimilar to Neulasta
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.
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Sandoz proposed biosimilar pegfilgrastim accepted by EMA
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review...
