Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.
Approvals for two Eylea (aflibercept) biosimilars have been granted by the US Food and Drug Administration, with both products also receiving interchangeability designations.
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Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.
The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.
With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.
In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.
In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
Generics Bulletin reviews global regulatory developments across the world.
