Biocon - The ultimate biosimilars play!

(eyesice) #268

Lupin and Yoshindo’s JV — YL Biologics announces successful outcome of global _=
Phase Ill study for Etanercept biosimilar in Rheumatoid Arthritis . In their board meeting held at Pune last week, YL Biologics (YLB) announced that a global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. YLB is the joint venture of Pharma major Lupin and Yoshindo in Japan.

“We are excited by the positive results from the Phase III trial. This helps us put together a robust regulatory
dossier intended for global regulatory filings for YLB113. We currently have multiple high value- biosimilar
candidates in our late-stage global development pipeline. We remain committed to advancing our biotech R&D
capabilities so that more patients across the world can access affordable, high-quality biosimilars” said Mr.
Nilesh Gupta, MD of Lupin Limited.

My query to fellow boarders is how long does it take to file the dossier and get regulatory approval since they have completed phase III trial? Also, Nilesh Gupta talks about other biosimilars in the pipeline. Could there be any overlap with Biocon’s product range?

(rskothari) #269

The_Silver_Lining_In_Pharma_Cloud_160318.pdf (1.0 MB)

A report by IIFL. IIFL has positive views on Biocon.

(ashit) #270

We have at least a five-year head start" in biosimilars compared with other Indian drugmakers, Mazumdar-Shaw

Biocon will need about $1 billion in investment The company is exploring fund-raising options, including selling some of its 73 percent stake in Syngene International, or allowing investors to buy a stake in its biosimilars subsidiary directly through a public offering


(ashit) #271

Approval for Glargine for Australia and Europe

The EC approval of Semglee™ applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.


(Gary) #272

I think this is hyperbole that’s typical of Ms just last week Sun Pharma got ilumya approval (tildrakizumab) that has eluded biocon so far.

(ashit) #273

Personally I don’t track Sun pharma and its biosimilars but it’s tildrakizumab is probably manufacturer by Samsung Biologics and only marketed by Sun pharma


I have invested in Biocon and following all statements of promoters since two and half years and reasonably satisfied with there promises and progress except FDA observations
Recent announcement of collaboration with Sandoz gives investors long term visibilities

As I am invested my views are bias

(Gary) #274

To my knowledge, Sun Pharma bought Tildrakizumab from Merck in 2014. Please see this -

(Mithun Raj) #275

Biocons Bangalore facility re inspected by EMA recently, outcome awaited (mins 5.40 attached video).
The Bangalore facility makes the insulin pens. As European commission has granted approval for Semglee disposable pens now, it probably means that the facility has cleared the reinspection. (The original CHMP positive opinion was for Semglee vials alone). Just my biased thought😏

(Ram Arvin) #277

One grey area is still we don’t know what is the profit sharing agreement between biocon and mylan, biocon and sandoz…how do you project the earnings…what is the valuation comfort to enter

(ashit) #278

Interview by KMS

  • Next 2 years will be good for company
  • Within 2 years 70 to 100 million top line is doable target
  • waiting for Bangalore facilities European approval
  • Malaysian facilities 386 will be cleared

(saumya) #279
Mulan and biocon to accelerate adalimumab in Europe via in licensing fkb.

(Mithun Raj) #280

Near-term catalysts for Biocon: Approval of biosimilar Neulasta in the U.S. (June 4), biosimilar Humira in EU (2H18), potential launch of biosimilar Herceptin in the U.S. (early 2019 or later as per settlement with Roche), and insulin glargine in E.U. (2H18)