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

Pfizer's Next Move.......After RA...its Oncology and Metabolic disorders.............

Pfizer has always been the company which intrigued me in many ways......the company which acted as a massive shark for quite long is being quite mum for a while....In Jan there was a buzz that the company is splitting its business in the similar ground to Abbott but there were no initiation activity from the company end. And then there aggressive movement in the Metabolic and immunology segment (Many of the compounds in Phase I/II) we still need need to check the company strategy going forward.....After its nutrition business sales it has cash in hand....will it go for Onyx deal to expand its portfolio in Oncology, as recently it collaborated for Cytomax for its ADC technology.........Will Oncology be the next game changer for Pfizer growth the way it has been for Roche?????.....Will it be able to displace Roche products in some oncology segments the way it’s trying hard to displace Humira in RA with its expected block buster product???????

Many things to watch from Pfizer's end!

Modern Healthcare touching millions of lives in India

In the last few years India as a favorable destination for medical treatment options as the hospital chains in India has well equipped themselves with facilities second to none. With blooming economy we can boasts of highly qualified doctors with specialization in different branches of medical science. Major advantage of being in India is the cost-effectiveness of treatments. Estimates claim that treatment costs in India start at around a tenth of the price of comparable treatment in developed countries, thus the healthcare system developed in India not only supports Indian patients but treatment spreads to all across globes including America’s and Europe

Major advantages of healthcare treatment options in India include:

ü  Low-cost medical treatment

ü  High-quality medical care

ü  Low TAT (Turn around time)

ü  Places of interest

ü  English-speaking staff

The hospitals chains (Both private, semi government hospitals are promoting themselves by believing in the mission of

·       -  Better Life: Consistently delivering compassionate care to the patients throughout their lives by the value of Seva and “Patient first” approach

·      -   Better Care: All the major hospital have take ISO certification which includes their being protocol driven, reflecting global best practices, and ensure that their patients consistently receive quality care all throughout their lives. 

·       -  Outstanding facility and services: All the facilities have been designed and implemented by international experts to meet the highest international standards of effective medical flows, patient safety, healing and comfort.

·         Innovation: leveraging technology to enhance patient care and outcomes. 

·      -   A legacy of Seva/Care: Hospital chains like Apollo hospital believe in the vision of “Touch a billion lives to create a better world and this is embedded in their genes and their philanthropic endeavors have touched more than 12 million lives till date 

·         -Value and relationship: The values ensure that everyone who enters the front door can count on the highest standards of values and a long-term relationship for rest of their lives

·        - Affordable excellence: Hospitals do understand that modern healthcare is expensive but all the hospitals are focused on being more affordable to their consumers providing them equivalent quality.

We see that all the major hospital chains in India are promoting these values all across the board; I believe that in a decade we will see a healthier India going forward as the legacy of seva, value, relationship and affordable excellence in going to increase day by day