The annual report of lupin is released
They are also at very advanced stage of biosimiliars approvals
One of drugs Mylan initially thought of tying up with biocon, they are now going with Lupin
The biosimiliars that biocon is developing will have a lot of competition as they are not the only one developing it
I am invested although I was under the impression that only biocon is developing biosimiliars until I read Lupin annual report today
You can’t expect profit lucrative segments to be competition free unless there is a barrier to entry. Here the only barrier is R&D superiority which most large Pharma companies have. Biocon has been the first Indian company to take the Biosimilar opportunity to global stage. FYI Cadila is the largest player in domestic markets in biosimilar category, and they are also going global.
Crossing all the hurdles, Biocon became the first Indian drug maker to get a US FDA approval for the biosimilar version of Trastuzumab in December. Having teamed up with Mylan, Biocon also filed its biosimilar to Pegfilgrastim for approval in US. The approval is pending due to a complete response letter (CRL) from the regulator.
Patel said he was enthused with Biocon’s approval.
Nevertheless, I feel Biocon should get some first-mover advantage in the near-to-medium term.
Competition will always be there. The only difference in biosimilars and pharma is - "limited competition " due to high development, trials, studies and infrastructure cost. So price erosion is relatively less.
If my understanding is correct, Mylan will launch Trastuzumab at 30% discount to innovator. Even if other players join in due course price erosion will not be 80-90 % that happens in ordinary pharma.
Biocon I believe will do 1000 Cr in this year and will hit 2000 Cr plus in next. And add another 1000 in next. Currently they are better placed compared to others. And ofcourse my belief is not always correct. I may be wrong.
Amgen Inc and Allergan Plc launched the first biosimilars of breast-cancer drug trastuzumab in the U.S., denying the Indian company exclusivity benefit.
The understanding was that Biocon would be the first to commercialise trastuzumab and enjoy six to nine months of exclusive sales, Deepak Malik, pharma analyst at Edelweiss Securities, said in an emailed response.
The U.S. FDA has approved three other trastuzumab biosimilars by Pfizer, Teva-Celltrion and Merck-Samsung, Malik said. If they launch before Biocon, the brokerage sees further risks to Biocon’s earnings.
Not good news for Biocon but not the end of the world as described in the article. Geez, what a sensationalist article!
Mylan had a secret deal with Roche (who owns the brand Trastuzumumab) in USA and Europe and that is why the biosimilar was not launched despite being approved in the USA. The details of the deal is not known, I am not sure whether Roche will compensate Mylan for the lost opportunity. Mylan is launching the biosimilar in the 2nd half of 2019 - not sure exactly when…
The “exclusivity” for the first 6 months is not applicable to biosimilars (as opposed to generics which are off patent and FDA approved for the first filer) - so the article is wrong and misleading in my view…
The uptake of biosimilars have been slow in the USA due to very strange reimbursement rules/mechanisms and hence it wont be easy for the biosimilars to snatch market share from the firm which holds the patent. This is especially true for a drug which is used repeatedly for years such as Trastuzumumab (as opposed to pegfilgrastim which is used only for short term whilst having chemotherapy for cancer - hence Mylan was able to snatch significant market share).
Discl - 23% of my portfolio and continuing to add
https://www.nature.com/articles/d41586-019-01401-5
A useful article about biosimilars (illustrates that uptake in India is highest probably due to low cost and lower regulatory hurdle, then EU and USA is lagging for strange reasons)
Uptake in Canada is also way higher (and switch to biosimilar drugs is compulsory in several states)
This is a risk that all companies face. Mylan deal is big positive, but this incident has certainly hit them.
Initiated a greenfield project at Visakhapatnam, Andhra Pradesh with an investment of Rs 600 crore to secure anticipated growth in fermentation-derived APIs, including a portfolio of immuno-suppressants… expects the facility to be operational over the next 3 years followed by commercialization based on regulatory approvals in major markets.
https://finance.yahoo.com/news/edited-transcript-biocon-nse-earnings-114904553.html
Udenyca share is 24 % of prefilled syringe market vs 21 % for fulphila as of May 2019 (Bloomberg symphony data).
This is inspite of biocon having a 6 month head start. Going forward, Udenyca will keep on gaining market share, as they already have inventories worth one billion$ ( 400000 doses). Fulphila market share ramp up will happen only once new capacities gets FDA approval (I expect a minmum 6 months lag).
An early Ogivri launch is what could stabilize Biocon share price in the interim. Amgen having a head start was an unexpected development, but a few months lag from Biocon in launching Ogivri wont have much material impact in gaining market share.
Also Kiran Shaw ( in a recent interview) was hopeful of launching Semglee by this year end/ early next year which I too believe, given the current political climate in US for cheaper Insulins and FDA observations at Malaysia facility being largely procedural in nature.
Even prior to Ogivri launch, Biocon had FDA issues, with initial FDA inspector’s report recommending for Official action indicated which would have resulted in no approval. This was later toned down to VAI in the EIR paving way for approval of Ogivri. Similar thing will likely play out with Semglee approval also. Luckily, Biocon has a couple of days gap between the lifting of 30 month stay (Sandoz) and transition of insulins from 505(b)(2) to BLA pathway to secure approval for Semglee. If this window is lost, expects another 1 to 1.5 years lag.
Biocon is making new 52 week lows, which will likely continue, but I think it’s a buying opportunity if you have a 1- 2 year time frame.
This is a very interesting article on Biocon Biologicals - https://health.economictimes.indiatimes.com/news/pharma/temasek-truenorth-cppib-seek-to-invest-in-biocon-biologics/70763254
Some excerpts:
Singapore’s investment company Temasek and homegrown private equity fund True North along with Canadian Pension Plan Investment Board (CPPIB) are separately in discussions to invest $300 million in Biocon Biologics India Ltd (BBIL) for a minority stake.
One of the sources said the unit may be valued upwards of $4 billion (Rs 28,000 crore) but this could not be independently verified. That would peg it higher than the listed Biocon’s market cap of Rs 26,190 crore.
The biologics business consists of biosimilars that include monoclonal antibodies and recombinant insulins and novel biologics. Biosimilars are identical copies of original biologic drugs that have active properties similar to the reference biological product requiring large clinical trials on patients to ensure safety before approval by regulatory agencies, unlike small generic molecules that can be launched by doing bioequivalence studies.
As a business, biologics are more complex structurally – highly sensitive to their manufacturing and handling conditions, making them more difficult to characterise and produce than chemical drugs. They are also more expensive compared with chemical drugs due to their complex structure, advanced research requirements, complexities in manufacturing but have a superior efficacy rate.
Earlier they had indicated that. “We have set up a new subsidiary Biocon Biologics, and all our biosimilar assets are consolidated under this legal entity, as we believe it will enable us to unlock value in the future,” said a Biocon spokesperson
So at some point in future, this unit might get hived off, maybe listed. What happens to the existing holders? If seniors could through some light.
They are already in the process of demerger and listing of biological business as independent entity.
That will be most likely be valued at more than current market cap of biocon.
Also, they are doing good in us market for rosuvastatin …
I also had a similar query. What happens to existing biocon shareholders once biocon biologics is listed ? Will we get proportionate shares in biocon biologics automatically or just preferential allotment during IPO. How was it when Syngene got listed? Anyone with experience, please respond. @rks00 @pikrohit
When syngene got listed Biocon shareholder got only preferential allotment in IPO
I think Branded products still contains biosimilars sales in gulf countries , emerging markets, and India also
Picture still not clear what shareholder will get they says it will be value unlocking for shareholders
Adding emotional statement 
we as a shareholder taken pain for more than five years for uncertainty of approval of molecules and FDA hurdles
Ideally we should get proportional share in Biocon Biologics
Thanks
Ashit
