July 17, 2017
clinical_dev_biosimilar

Ongoing Biosimilar Clinical Development in Oncology

As the regulatory frameworks for biosimilar development are evolving in both US and EU, more and more biosimilar developers are entering the competitive landscape. Many commercially successful Oncology biologics are going off-patent in next few years, presenting a lucrative opportunity for biosimilar development. The biosimilars pertaining to these biologics constitute […]
June 19, 2017
Biosimilar dev in US and EU

Biosimilar Regulatory Development in US and EU

As per the 2015 IMS report, the global biologics market is projected to reach 28% of the global pharmaceuticals market by 2020 [1]. This would translate to the biologics market potentially worth USD 390 billion in 2020. As many of the biologics will face patent expiration in the next 5 […]
June 5, 2017

India In The Global Biosimilar Play

In part 1 of this two part paper, we indicated that even as the western markets are opening up to mAb biosimilars, Indian biosimilar companies have focused on home turfs. In the absence of a crystal ball and presence of several caveats, there is no telling how the market will shape […]
June 1, 2017
Biosimilar The India Story

Biosimilars- The India Story

Conspicuous By Absence In US And EU The floodgates have opened for the first wave of the monoclonal antibody (mAb) biosimilars in the two most rewarding pharmaceutical markets US and EU. As several big pharmaceutical companies are gearing up for the opportunity, the Indian companies are conspicuous by their absence. […]
May 18, 2017
Biosimilars ASCO 2016

Biosimilars at ASCO 2016

Mylan’s Phase 3 clinical read out was the biosimilar show stopper at ASCO 2016. The biosimilar awareness amongst the attendees was reflected by the full house attendance of biosimilar sessions and presentations throughout the conference. The clinical data from the Phase 3 HERiTAge study, comparing Mylan’s MYL-1401O, potential trastuzumab biosimilar […]
May 16, 2017
Biosimilars ASCO 2015

Biosimilars at ASCO 2015

The year 2015 marked the approval of the first biosimilar via the BPCIA pathway in USA. The murmurs of biosimilars could be heard in the corridors of ASCO-2015. A total of 3 clinical read-outs and industry sponsored activities marked the largest oncology congregation of 2015. Russia-based biosimilar developer, Biocad presented […]