Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars
The company will not commercialize an insulin glargine copy already tentatively approved by FDA as Lusduna, but says it remains committed to biosimilars in oncology and immunology.
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Biocon has run into fresh trouble with the US Food and Drug Administration after receiving a complete response letter on its application for insulin glargine, a proposed rival to Sanofi’s top-selling Lantus biologic.
The US FDA has slapped Biocon with a dozen observations over three units at its insulin manufacturing facility in Malaysia, but the Indian biotech firm says the problems can be remedied quickly and that US launch plans are on track for its insulin product glargine challenging French drug-maker Sanofi’s multi-billion-dollar Lantus.
In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.