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Biocon says ‍U.S. FDA issued complete response letter for proposed biosimilar Pegfilgrastim​


Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - Biocon Ltd ::Says ‍US FDA issues complete response letter (CRL) for proposed biosimilar Pegfilgrastim​.Says ‍CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity​.Says ‍do not expect CRL to impact commercial launch timing of biosimilar Pegfilgrastim in US​.‍CRL relates to pending update of BLA with certain data from facility requalification activities post recent plant modifications​.