Thursday, April 14, 2016

Update on Samsung's Benepali

Samsung Bioepsis and Biogen's Benepali (Enbrel Biosimilar) received approval by EMA on Jan 2016.  Samsung has already launched the European production in UK and the drug has already been launched in  UK, Norway, Germany, and Netherlands. Today Benepali got approval by Danish regulatory authorities and the collaboration expects to capture 50% of the originator market as local hospitals and doctors favor prescribing drugs selected by the procurement agency. Benapali is been sold at 40 to 50% less price compared to the originator.

The collaboration is actively promoting the uptake of Biosimilar all over EU market. Both Samsung Bioepsis and Biogen are enjoying the first mover advantage before the the upcoming European approval for Sandoz Enbrel Biosimilar. 

Samsung Bioepis has gained approval of its biosimilars for Remicade and in future will try to get approval for Roche’s Herceptin, and AbbVie’s Humira Biosimilar. The company has a Phase I clinical trial underway for its Avastin Biosimilar, currently, Bioepis has been  valued at $8 Bn and is trying to be listed on the Nasdaq. Samsung Bioepis has set a target revenue of $872 Mn by 2020.

After Sandoz , we have Daiichi and Coherus Biosciences Enbrel Biosimilar study going on which has met primary end point for PIII trial in Jan 2016 and now regulatory submission has to start. Rest around 8 companies are working on Enbrel Biosmilar, some have received approval in the semi regulated market and we have to see if the approved product in the non regulated and semi regulated market will be going ahead and be part of the second wave of Biosimilars 

The originators meanwhile are reducing Enbrel price at their end and probably will be using their age old bundling approach for drug uptake

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