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 22, 2017

Future of Cancer Care 2030 – RAS Viewpoint

There are four areas of innovation that are noticeable both in isolation and how they feed into each other for a transformation in cancer care “Big data” and Bioinformatics – rapidly developing data management systems and analytics e.g. NGS that will enable us to collect, analyze and learn from vast amounts […]
April 12, 2017
Operational Challenges in Biosim

Operational Challenge in Biosimilar Development

A biosimilar product is essentially a non-inferior ‘twin’ of the reference biologic with similar clinical efficacy and safety. Biosimilar development is a fairly new and evolving landscape with many unique operational challenges. This blog explores some of these challenges and ways to overcome the barriers. The regulatory approval requires biosimilar […]