May 16, 2017
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 […]
April 12, 2017
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 […]
April 3, 2017
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 You may go through the draft guidance upon following the link.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 […]
April 3, 2017
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, […]
March 31, 2017
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 […]