Industry Trend Analysis - Trastuzumab Approval Marks Samsung Bioepis As A Biosimilar Leader - FEB 2018


BMI View: Samsung Bioepis ' biosimilar programme is proving to be highly successful, with five of six projects having now received approvals from various regulatory agencies, including those in the EU and US. This latest EC marketing authorisation is the first EU approval for a trastuzumab biosimilar, giving Samsung Bioepis a head start over arguably more established potential versions. Roche can anticipate sales for Hercpetin in Europe will be hit, but these revenues are already falling, in part as Roche is encouraging its own replacement. As a result, the full impact on Roche will be questionable.

The EC has granted marketing authorisation for Samsung Bioepis' Ontruzant, a biosimilar version of Genentech ( Roche)'s Herceptin (trastuzumab). The move makes Ontruzant the first trastuzumab biosimilar to receive regulatory approval in the EU. The biosimilar will be commercialised by Merck Sharp & Dohme ( Merck & Co).

The EMA's CHMP adopted a positive opinion, recommending approval of Ontruzant, in September 2017, noting that the product is highly similar to Herceptin, which was authorised in the EU on August 28 2000. Data show that Ontruzant has comparable quality, safety and efficacy to Herceptin.

European Ontruzant Sales Likely To Increase Decline In Herceptin Sales
Roche's Annual Herceptin Sales (CHFmn)
Source: Roche, BMI

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