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Latest From Anju Ghangurde
The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.
Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Sanofi has sought to block an alleged infringer's attempt to ride on its trademarks, trade name and logo in India; the French multinational views these activities as intended to cause confusion among consumers.
Cipla has outlined its intent to incubate disruptive ideas in the healthcare space, along the lines of similar initiatives to accelerate innovation from US/European big pharma. It hopes that this "culture" will expand in India.
Is there a new strategic Asian pharma partnership in the works? Early days perhaps but worth keeping an eye on the India-South Korea deal street.
The first FDA-approved Neulasta biosimilar is here, opening up material earnings opportunities for partners Mylan and Biocon and affirming the duo's ability to deliver on their complex but high-value pipeline.