The US Food and Drug Administration (US FDA) has issued a Complete Response Letter (CRL) for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim (cancer drug). This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.
Complete Response Letter is a communication by the US FDA asking for more information in terms of the application. The CRL can be anything; they could have a problem with the drug, they could have a problem with the plant. It could just be to-and-fro in terms of incremental exchange of information.
In an interview to CNBC-TV18, Vishal Manchanda, Pharma Analyst at Nirmal Bang Institutional Equities shared his views and readings on the news as well as on Biocon stock.
Manchanda said the CRL is not as severe as one would have anticipated.
"We should not react to this news and rather wait for the approval because there are other hurdles in terms of litigation," he said.
We were estimating second half of next year as a launch timeline but there are other variables too in terms of how the competition shapes up, said Manchanda.
He further said that it would not be wise to change earnings per share (EPS) estimate with the CRL.Watch accompanying video for more details.