The Enbrel biosimilar race just got tighter. Sandoz said Monday that it is launching Phase III trials of an etanercept biosimilar after hashing out the details with both European and US regulators.
The company said in a statement that it expects to use the global clinical trial results to support filings in both geographic areas for severe chronic plaque-type psoriasis. Enbrel is approved for moderate-to-severe plaque psoriasis, rheumatoid arthritis and psoriatic arthritis. Although the US has yet to establish a biosimilars approval protocol, the general feeling is that the rules are coming, and pharmaceutical pipelines are being readied to take advantage of the approval pathway once it does open.
Sandoz, Novartis’ generics subsidiary, already has experience marketing biosimilars in the US, since an earlier drug got through via an alternate channel. The firm told MM&M in a prior interview that the lesson learned from launching that drug, growth hormone Omnitrope, was that biosimilar makers have to back the products with a support system that mimics that of a new-to-market drug as opposed to traditional generics, which have generally followed more of a linear, make-and-distribute sell pattern.
Enbrel has also been in the news lately because Amgen is preparing to dial back Pfizer’s share of the royalties, when the US co-promotion agreement between the two firms ends later this year. The biologic, which earned about $4 billion in US sales last year, competes with the likes of AbbVie’s multi-indication Humira, and much cheaper combinations of older medications, for those interested in lower-tech RA treatments.
