expert corner
SECOND WAVE OF BIOSIMILAR DEVELOPMENT IN OFFING
The full potential of the biologics is yet to be realized and there is a strong pipeline of new products lined up in next few years , writes Dr Charu Manaktala
Biologics with patents expiring between 2015 and 2020 constitute the second wave of biosimilars . These include biosimilars of top selling products such as Humira ®, Enbrel ®, Rituxan ®/ MabThera ®, Avastin ®, Herceptin ® and Remicade ®. One infliximab biosimilar ( Celltrion / Hospira ) is already approved and marketed in the European Union , and one etanercept biosimilar ( Samsung ) has very recently received positive opinion from the EMA ’ s Committee for Medicinal Products for Human Use . There is a large pipeline of other biosimilars in different stages of development . This area is already crowded , with more than 160 biosimilars reported in different stages of development for these six top selling biologics . Till recently we did not see any significant biosimilars development activity for the third wave of biologics with patent expiries beyond 2020 ( e . g ., Cimzia ® - certolizumab pegol , Lucentis ® - ranibizumab , Simponi ® - golimumab , Stelara ® - ustekinumab , Soliris ®
There is a large pipeline of other biosimilars in different stages of development . This area is already crowded , with more than 160 biosimilars reported in different stages of development for these six top selling biologics .
- eculizumab ). One important factor for this is the lower market value of these products ( relative to the likes of Humira ®). Now early signs of interest in these biosimilars are beginning to emerge . The coming years are likely to see biosimilars for these biologics feature in the clinical development pipelines of at least some of the companies .
A look at pricing of biologics and biosimilars :
Price Competition to Continue Spurring the growth of biosimilars is the need to improve access to biologics and contain treatment costs and healthcare budgets . When the first biosimilars were launched in the European Union , they were priced at a 20 to 30 percent discount to the branded product , to start with . As the market has progressed , innovators are dropping their prices in order to retain their market share , and biosimilar manufacturers are dropping their prices even further – with discounts reaching as deep as 70 percent of the innovator ’ s price in some cases . This trend is likely to continue with the launch of more biosimilars . Experience from Norway shows that the uptake of biosimilars is strongly linked to the discount offered . As Remsima ® ( Bs infliximab , Orion ) discounts increased to 70 percent from 40 percent , the market share
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BioVoiceNews | May 2016