In March 2020, Insulin was officially moved to biologic regulatory framework by US FDA. This coupled with new guidelines on relaxation in comparator clinical trials data may prove to be boon for entry of cheaper Insulin Biosimilars in the US. Otherwise the many diabetes patients in the US are unable to afford treatments due to very expensive Biologics, and some industry reluctance towards giving easy walk over to cheaper Biosimilars. The entry of interchangeable insulin biosimilars are expected to bring down cost of treatment. Whereas in EU the first insulin biosimilar was approved in 2014, and it was priced 15-35% lower than the Biologic. Currently EU and APAC together cover significant portion of insulin biosimilars market. Whereas the recent guidelines by US FDA may see new biosimilars getting approvals in the US market very soon.
As per some studies conducted in the UK the direct cost of managing diabetes in UK alone is close to GBP 14 Bn per year in 2018. As well as insulin alone costs NHS an estimated GBP 82 Mn per year. There are currently two biosimilars insulin available in UK i.e.
Sanofi have recently got positive review from EMA’s Committee for Medicinal Products for Human Use (CMPH) for authorization process for its Biosimilar, Insulin Aspart. The Biosimilar, insulin aspart 100 units/ml, is a version of Novo Nordisk’s NovoRapid. With this positive approval the company is more confident of getting MA for EU in very near future. Whereas post guidelines issues by US FDA other companies such as Biocon and Sandoz are pushing to get some of their products approved in US markets.
On the other hand the innovators such as NovoNordisk and Eli Lilly are also trying to bring their own products’ biosimilars, but the market sentiments remain grim since in many cases it is reported that those biosimilars are mostly not available in pharmacy stores.
Competitive profiles will include companies like Novo Nordisk, Eli Lilly, Biocon, Sandoz, Sanofi, Mylan, Boehringer Ingelheim Gmb, Momenta Pharmaceuticals, etc.
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