Open AccessINDIAN PHARMA INDUSTRY – WHAT’S NEXT?
Author(s) -
D. Shenoy
Publication year - 2018
Publication title -
indian drugs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.121
H-Index - 31
ISSN - 0019-462X
DOI - 10.53879/id.55.10.p0005
Subject(s) - innovator , medicine , transformative learning , product (mathematics) , refractory (planetary science) , family medicine , business , intellectual property , psychology , political science , biology , law , pedagogy , geometry , mathematics , astrobiology
Dear Reader, I am honored to contribute this Editorial feature for the Indian Drugs. The timing couldn’t have been better – as our industry is poised at the inflection point to takeup the next challenge. Let me start with two exciting stories related to innovation in the pharmaceutical industry: one related to a break-through innovation and the other related to an incremental, yet very important innovation. First, the break-through innovation. KYMRIAHTM (Tisagenlecleucel suspension for intravenous infusion; innovator – Novartis) became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory (US-FDA) approval in August-2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. In May-2018, it received approval for the second indication by US-FDA – the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma. KYMRIAHTM has become a landmark product in the field of personalized and transformative medicine – wherein the product is manufactured individually for each patient using the patient’s own T cells.