I have been working in the field of Biosimilars for past 10 years.
First in the process of cloning to pilot scale purification process, then later
moved into IP and then CI projects for Biosimilars. I am enjoying the way the
scenario is changing for the biosimilar in terms of manufacturing,
planning of clinical trials and then the over all customer engagement
initiatives happening at different company level.
Yesterday FDA's independent committee of 24 members, 21 in favour
and 3 in opposition offered opinion on the quality, safety and cost
effectiveness of Celltrion’s Remsima Biosimilar. This committee's view
will not determine the approval but its opinions will largely influence FDA's
decision. Remsima will be used for treatment of rheumatoid arthritis, ankylosing spondylitis,
ulcerative colitis, Crohn’s disease, psoriasis and psoriatic arthritis.
Some analysts expect Remsima to be
introduced in the United States by 2018 but I assume that Remsima will be
approved by Q3, 2016 and slow uptake will start happening from Q4 2015 to Q1
2016 onwards. Celltrion has not disclosed what they might charge for
Remsima, but a substantial discount is expected. What’s there after Q2, 2017 is
to watch for?????
