Biocon, Viatris application for Insulin Aspart rejected by USFDA
New Delhi: Biocon Biologics, a subsidiary of biotechnology major Biocon, on Friday said the US health regulator has not approved an application for Insulin Aspart filed by its partner Viatris Inc.
"The USFDA has issued a complete response letter (CRL) for the biologics licence application (BLA) for Insulin Aspart filed by our partner Viatris (Mylan)," a Biocon Biologics spokesperson said in a regulatory filing.
The company will respond to the CRL to satisfy the FDA's requests, it added.
The CRL did not identify any outstanding scientific issues with the product," the spokesperson noted.
"As per the USFDA, a CRL is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form," reports PTI.
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Biocon Biologics has a platform of 28 biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases.
Five molecules from Biocon Biologics' portfolio have been taken from lab to market, of which three have been commercialized in developed markets like United States, EU, Australia, Canada and Japan.
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