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 […]
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 […]
Biopesticides are used for high-quality crop yield for the increasing population and growing organic food demand. Many multinational players have entered into the research and development of biopesticides for diversified crop types. It presents a business opportunity in coming years.
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 […]
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 You may go through the draft guidance upon following the link.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 […]
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, […]