Biocon Staying Firm On Insulins Path, Including Glargine
Biocon has reported strong second-quarter earnings and underscored its interest in the insulins space, including insulin glargine, at least for now. Merck & Co recently called off plans to commercialize its Lantus version.
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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.
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.