After Remicade Biosimilars........the next ones are Adalimumab Biosimilars

Three years back Remicade Biosimiliar was released in EU and this quarter the same Celltrion Biosimilar got approved in US. Now its the turn for Biosimilars for Adalimumab.

As of now Amgen's ABP 501 Phase III trials  are going on  in the European Union and for US positive results for it's phase III trial in arthritis were announced in February 2015. The company has submitted application for approval in  US FDA on November 2015 and to the EMA on December 2015. 

Amgen will have the first mover advantage to market the Biosimilar in both US and EU market, Amgen already has a strong hold in the biological space in both the continents and has been in the part of the lobby which is promoting Biosimilars uptake and approval in the US market for long, so i assume that it will have a better uptake in the US market by 2020 

After Amgen it will be Sandoz and  Boehringer Ingelheim (BI), Germany which will have the second and third mover advantage. Now Abbvie, which has been boasting all about its Humira franchise will not have much affect in its revenue till Q3- Q4 2017 from the First wave of Biosimilars. But from Q2- Q3, 2018 onwards it may feel the heat

And by the time second wave of Biosimilar happens i am sure that Amgen and Sandoz together will capture around as much as 30-35% of the market and BI will have to make its presence felt in the Biosimilar space as it has no credibility till date in Biosimilars

The advantage for both Amgen and Sandoz are that they veterans in the Biologic & Biosimilar space and they are a strong brand themselves and by 2020 they shall have more Biosimilars approved and more Phase 4 study data for their Biosimilars application in various indications , so i assume that Amgen and Sandoz  will be able to capture around 30 to 35% of market..

For BI we have to see how its promoting its Biosimilars by 2020. Also by 2020, we will have more players like Pfizer, Oncobiologics, Fuji (Emerging Markets) coming up as part of second wave for Biosimilar. 

India perspective   we have the Biosimilar for Adalimumab launched in India and i shall capture it in the later parts 

Note:The reason i have provided the ranges between 30- 35% is as per the survey data for Remicade Biosimilar uptake in EU (Data can be skewed thus taken a conservative estimation)

Another Milestone For Emerging Biosimilar Companies

Celltrion received Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: -Adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; -Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; -Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; -Patients with active ankylosing spondylitis (arthritis of the spine); -Patients with active psoriatic arthritis;adult patients with chronic severe plaque psoriasis. After Positive node from FDA for its safety and efficacy, we were expecting an approval by Q3 2016. This was a pretty fast approval from FDA's end. Also Celltrion is coming up with more Phase 4 data, which i shall be collating in my next update As i track the generic companies in India, i have observed that FDA's has fasten its process both the generic and other approval. Also to note is that Samsung Bioepis (South Korea) has also received recommendation from EMA for its in-development biosimilars: Flixabi, a biosimilar of Janssen’s blockbuster Remicade for Inflammatory diseases.

CMO to Biosimilar developer journey

What is common between Celltrion, Samsung Bioepsis, Biocon and Oncobiologics ??????

All these companies are actively promoting themselves as one of the leading contract manufacturing companies for both Biopharmaceuticals and Biopahrma production and have formed alliances with major companies in the regulated market during Biosimilar drug development process. The first three already have marketed products in regulated market and Oncobiologics which was formed in year 2011 has already finished P1 clinical studies for ONS -3010 (Humira Biosimilar) and ONS- 1045 (Avastin Biosimilar and i assume the said mAb's to enter P3 clinical studies by early 2016

In the span of less than 10 years these companies have evolved as a major biosimilar developer in their specific countries...its a great achievement till now....

Now we need to see how the generic players who have already marketed products  and are developing their Biosimilar portfolio will be evolving as a third party vendor in the developing world for the major Pharma's. Let see how the landscape evolve in the coming years.....

Biocon the game changer for Biosimilar’s from India

Biocon for past sometime is developing its biosimilar portfolio with state of the art Biopharma production unit in India and in Malaysia. Biocon-Mylan Biosimilar’s partnership is progressing well as company is planning to file upto 5 biosimilars in EU and US. In 2014, the company became the first biosimilar company to launch Roche’s Herceptin copycat “Canmab” in India but now it is planning to launch this product along with four other biosimilars which are in development phase.

According to the company latest update  

1.       Insulin Glargine global Phase III trials were completed in the first quarter of this fiscal,

2.       Patient recruitment for multi-centric global Phase III for Pegfilgrastim and Trastuzumab are nearing to their completion while the global Phase III clinical trial for

3.       Adalimumab PIII trial is in progress across multiple sites.

4.       Bevacizumab PI PK studies is approaching completion while the ROW focused Phase III trial is advancing as per plan

Today the company announced that Japanese Ministry of Health, Labour and Welfare (MHLW) has given approval to its insulin Glargine Biosimilar. This approval will give Biocon and its partner, FUJIFILM Pharma, opportunity to bring quality and affordable medicines for diabetes patients in Japan

What surprises me is that Biocon is the late entrant in the Biosimilar space, Dr Reddy’s, Intas and Wockhardt were already in the space last decade in terms of small molecules and mAb’s. What is taking these companies so much time to go ahead for their products launches from semi- regulated to regulated market. 

In 2013 Dr Reddy’s said that it is planning to launch its Bioismilar products in EU in next 5 years. 3 years are already over but it has not yet started PIII clinical trials for the same in the regulated market, what is it doing??

Celltrion's Remsima.......

I have been working in the field of Biosimilars for past 10 years. First in the process of cloning to pilot scale purification process, then later moved into IP and then CI projects for Biosimilars. I am enjoying the way the scenario is changing for the biosimilar in terms of manufacturing, planning of clinical trials and then the over all customer engagement initiatives happening at different company level.

Yesterday FDA's independent committee of 24 members, 21 in favour and 3 in opposition offered opinion on the quality, safety and cost effectiveness of Celltrion’s Remsima Biosimilar. This committee's view will not determine the approval but its opinions will largely influence FDA's decision. Remsima will be used for treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, psoriasis and psoriatic arthritis.

Some analysts expect Remsima to be introduced in the United States by 2018 but I assume that Remsima will be approved by Q3, 2016 and slow uptake will start happening from Q4 2015 to Q1 2016 onwards. Celltrion has not disclosed what they might charge for Remsima, but a substantial discount is expected. What’s there after Q2, 2017 is to watch for?????

RNAi Technology - The charm is it existing or fading away.......

New job as a sales person is completely different and every place has a different way of working, suddenly out of blue my hubby (A computer geek) asked me about RNA and then the difference from DNA, so i started explaining to him the difference between the both and how in last decade the hype of treating with RNA came into existence .....i some how feel that the charm of developing RNA therapies has gone to back shelf , and new technologies like ADC's are taking their place with much better results.

In late 2000's did some consulting projects for a company, which later went ahead with acquisition of one small innovative company based out of US. I have been tracking the companies update but now not much buzz is happening from their end......

Hope to see traction in the segment going ahead!

2013 Update...

After a long hiatus, i am back with a bang....life was becoming pretty hectic as i was required to change job, city and home....so after long time i am blogging something.....

Pharma industry there were acquisitions happening, but not like the big ones which happened last decade. Valeant was in a spree for deal, like wise Bayer moving ahead with its M&A deal. Pfizer was playing safe. Like Abbott last year split its division into two, like wise Pfizer and Eli lilly decided to move ahead with split and consolidation of some of its BU units.

Medical devices industry there were lot of M&A activity and approvals, but we have more to look forward in this year from the emerging markets

Biosimilars were creating lot of noise, with the first biosimilar in immunology approved in EU, this year we need to look at the market. Both physician's and patients response to the drug in terms of its safety and efficacy.

Companies in 2014 to watch : Celltrion, the biggest CMO for biologics/Biosimilars. Is it really there for sale?
Roche is continuously bolstering its Oncology portfolio.

More to come in Next article......

Novartis will it go Pfizer and Abbott way!

Last year Abbott went ahead with a spin off into two major business units, following that for Pfizer speculation started to surface that it is also going for Split off in early Jan 2013, but yes the decision came in July about splitting of the company. Now it’s turn for Novartis as the CEO announced that he is certainly going to make some changes.....what we have to see if Chiron will still exist in the port folio or they will merge it with Pharma Biological and Vaccine innovation research....time will tell what will be the next steps for Novartis