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??