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BRIEF-Biocon says ‍U.S. FDA issued complete response letter for proposed biosimilar Pegfilgrastim​
October 10, 2017 / 3:27 AM / in 2 months

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

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​ Source text: bit.ly/2g7cCrs Further company coverage:

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