Blogs

Operational Challenges in Biosim
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 Continue Reading
 Categories : Biosimilars, Disease Area Strategy Posted by Richa Agrawal  
Interchangeable Biosimilars
Finally, FDA has come out with its interchangeability guidelines.  The US drug regulatory agency has presented its recommendations for the data requirement for a biologic product to be interchangeable to a reference product. You may go through the draft guidance upon following the link. As per the FDA guidelines, an Continue Reading
 Categories : Biosimilars, Disease Area Strategy Posted by Richa Agrawal  , ,
Combating biosimilars
The Oncologic Drugs Advisory Committee (ODAC) of FDA has unanimously recommended approval of subcutaneous (SC) rituximab for the treatment of patients with certain blood cancers. A final approval to this effect is expected by June 26, 2017 (Official Announcement). The approval of SC formulation certainly has its benefits such as, Continue Reading
 Categories : Biosimilars, Competitive Analysis, Product Strategy Posted by Richa Agrawal  ,
Biosim go to market strategy
Commercialization is the next frontier for biosimilar developers. As more and more biosimilars are gaining regulatory approvals, the discussion on commercial aspects of the yet evolving market is gaining momentum. Biosimilar commercialization will have its very specific attributes and nuances. Biosimilars are neither first- nor best- in class products, these Continue Reading
 Categories : Biosimilars, Product Strategy Posted by Richa Agrawal  ,
65 big/small/medium Pharmaceutical companies and 10 publishers took part in the ESMO. A white based theme was observed for all the booths in the ESMO Exhibition area. The booths attracted a lot of footfall and were packed right from day 1 of the conference.  Most of the companies of our Continue Reading
 Categories : Conference Coverage Posted by Sakshi Saini  

26December

1L EGFRm+ NSCLC

AZ Shows Off osimertinib setting the groundwork for move into 1L EGFRm+ NSCLC AZ´s symposium presentations focused on promoting the value of 3rd Gen TKIs and liquid biopsies. AZ took the opportunity to emphasize that osimertinib is the only 3rd Gen TKI in the market highlighting the discontinuation of rociletinib Continue Reading
 Categories : Conference Coverage Posted by Sakshi Saini