Biocon rises 3% on complete response letter for proposed biosimilar pegfilgrastim
The US Food and Drug
Administration has issued a complete response letter (CRL) for Mylan's
biologics license application (BLA), a proposed biosimilar pegfilgrastim.
Shares of Biocon added 3.4 percent intraday Tuesday on the back of complete response letter (CRL) from USFDA.
The US Food and Drug
Administration has issued a complete response letter (CRL) for Mylan's
biologics license application (BLA), a proposed biosimilar pegfilgrastim.
This said product is a part of
the biosimilars portfolio being developed jointly by Biocon and Mylan. The CRL relates to the pending update of the BLA with certain
CMC data from facility requalification activities post recent plant
modifications.
The CRL did not raise any
questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data
or immunogenicity.
"We do not expect this CRL
to impact the commercial launch timing of biosimilar pegfilgrastim in the US.
We are committed to working with the agency to resolve the issues stated in the
CRL expeditiously," company said in release.
The board meeting of Biocon is
scheduled to be held on October 26, to consider, approve and take on record,
the un-audited financial results (both standalone and consolidated) of the
company for the quarter and half year ended September 30, 2017 amongst other
routine matters.
For more information visit our site: www.capitalways.com
Share story
0 comments: