What’s Next? Five Things To Look Out For In January
Humira’s US LOE Finally Arrives And Key Appointments Shape Industry
The biggest loss of exclusivity in pharmaceutical history is set to steal headlines in the first month of 2023, as Teva begins a new year with a new CEO.
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Another US Humira Biosimilar Approved As Formularies Offer Access
As Fresenius Kabi receives US FDA approval for its Idacio rival to Humira, positive developments are being seen in terms of adding adalimumab biosimilars to local formularies. Meanwhile, in Europe Stada and Alvotech have broadened access to their Hukyndra high-concentration version.
Humira LOE Is ‘Uncharted Territory’ As Fierce Competition Expected
Discussing the latest developments in the US biosimilars market, AmerisourceBergen’s senior director of biosimilar commercialization, Brian Biehn, talks about what we can expect from competition to Humira in 2023, how the first ophthalmology biosimilars are faring, and potential changes on the horizon at the FDA that could smooth the path to market for biosimilars sponsors.
Brazilian Regulator Consults On Improving Rules For Registering Biosimilars
ANVISA, Brazil’s medicines regulator, is asking for feedback on the regulatory pathway for biosimilars.