@rks00 FDA 483 for Biocon May 2018
Thought I’d share this article detailing the 340B change implications for Neulasta. The article is from earlier this year, but basically talks about the kind of market share that any biosimilar competitor can capture in a relatively short period of time.
Coherus’s projection is 13% or $500 Mn / year. We unfortunately don’t know the profit sharing arrangement between Mylan and Biocon, but for a company (Biocon) with $100 Mn in PAT, this could be a big deal. Fingers crossed for Monday!
U.S. FDA Approves Mylan and Biocon’s Fulphila™
(pegfilgrastim-jmdb), the First Biosimilar to Neulasta®
Why Prices is going down? inspite of giving approval
Good read about the State of Affairs in the Pharma sector and the future, as told in Lupin’s recent presentation here -
Biocon is the most prepared to reap the rewards in this future growth phase…though biocon never participated in the early stages, unlike the rest of the generic leaders.
“Buy the rumor and sell the fact” is happening here I think. Any way can’t believe that Biocon is the 4th pharma company in India by market cap. It will soon be 2nd after Sun in my view.
This years EPS is 6.21. My prediction for FY19 EPS is 18-20 (my guesstimate). The reason being peg-filgrastim sales in the US and glargine sales in Europe and Australasia.
Let us see what happens!
Life struggle of KMS
The Company confirms that Biocon has received an Establishment Inspection Report (EIR) from the USFDA for its Sterile Drug Product manufacturing facility in Bangalore, following the USFDA pre-approval inspection of this facility in April/ May 2018. EIR notifies that the inspection stands closed. Biocon is committed to global standards of quality and compliance.” Company Spokesperson
Biocon’s Sterile Drug Product facility receives EU GMP Certification https://www.bseindia.com/xml-data/corpfiling/AttachLive/8854f50c-3a6d-4d08-aac1-e9eb9602376c.pdf