Monday, April 11, 2016

After Remicade Biosimilars........the next ones are Adalimumab Biosimilars

Three years back Remicade Biosimiliar was released in EU and this quarter the same Celltrion Biosimilar got approved in US. Now its the turn for Biosimilars for Adalimumab.

As of now Amgen's ABP 501 Phase III trials  are going on  in the European Union and for US positive results for it's phase III trial in arthritis were announced in February 2015. The company has submitted application for approval in  US FDA on November 2015 and to the EMA on December 2015. 

Amgen will have the first mover advantage to market the Biosimilar in both US and EU market, Amgen already has a strong hold in the biological space in both the continents and has been in the part of the lobby which is promoting Biosimilars uptake and approval in the US market for long, so i assume that it will have a better uptake in the US market by 2020 

After Amgen it will be Sandoz and  Boehringer Ingelheim (BI), Germany which will have the second and third mover advantage. Now Abbvie, which has been boasting all about its Humira franchise will not have much affect in its revenue till Q3- Q4 2017 from the First wave of Biosimilars. But from Q2- Q3, 2018 onwards it may feel the heat

And by the time second wave of Biosimilar happens i am sure that Amgen and Sandoz together will capture around as much as 30-35% of the market and BI will have to make its presence felt in the Biosimilar space as it has no credibility till date in Biosimilars

The advantage for both Amgen and Sandoz are that they veterans in the Biologic & Biosimilar space and they are a strong brand themselves and by 2020 they shall have more Biosimilars approved and more Phase 4 study data for their Biosimilars application in various indications , so i assume that Amgen and Sandoz  will be able to capture around 30 to 35% of market..

For BI we have to see how its promoting its Biosimilars by 2020. Also by 2020, we will have more players like Pfizer, Oncobiologics, Fuji (Emerging Markets) coming up as part of second wave for Biosimilar. 

India perspective   we have the Biosimilar for Adalimumab launched in India and i shall capture it in the later parts 

Note:The reason i have provided the ranges between 30- 35% is as per the survey data for Remicade Biosimilar uptake in EU (Data can be skewed thus taken a conservative estimation)

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