Leah Christl, head of the US FDA's biosimilar program, talks to Kate Rawson about the progress to date on applications, how her office interacts with sponsors unfamiliar with the regulatory process and the biggest hurdles companies face in biosimilar development. Here’s one surprise: sponsors are starting to use FDA/EMA’s parallel scientific advice program for biosimilars applications – most often in cases where there are differences of opinions between regulators.
Podcast: FDA’s Leah Christl Talks Biosimilars
US agency's Associate Director for Therapeutic Biologics Leah Christl gives the most up-to-date snapshot of biosimilar regulatory development, the potential areas for further FDA collaboration with European regulators – and how long it may be until the agency approves the first interchangeable biosimilar.
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Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.