As the world's best-selling drug, AbbVie's ($ABBV) Humira has a biosimilar target painted on its back--and Baxalta ($BXLT) is the latest to take aim.
The recent Baxter ($BAX) spinoff announced last week that it and partner Momenta Pharmaceuticals ($MNTA) were taking a copy of AbbVie's behemoth into Phase III trials. If all goes well at that stage, they'll be looking at their first regulatory submission in 2017 and a first rollout in 2018.
They're hardly alone. Plenty of companies are eager to snag a piece of Humira's $12.5 billion sales haul, among them Amgen ($AMGN); biosimilar hotshot Novartis ($NVS); and Merck & Co. ($MRK)--which is plotting global regulatory filings with partner Samsung Bioepis after putting up positive Phase III results this July.
Unfortunately for AbbVie, industry watchers expect the copycats' market-share snatch to work. In June, biosimilar industry members, payers, regulators, lawyers and healthcare investors participating in a Bloomberg Intelligence survey predicted that biosimilars for Humira will be the most successful copycat biologics launched in the U.S. and Europe.
The question is just how soon they'll begin to take hold--and on that, analysts disagree. Citi's Andrew Baum, for one, thinks Humira will fall hard and fast, with sales beginning to sink in 2018. In a February note to investors, he forecast the med's revenues declining from $16 billion at their peak in 2017 to $6 billion in 2022.
The way Suntrust analyst John Boris sees it, though, AbbVie will have time to extract "maximum value" from the franchise through volume gains, pricing, label expansion, a new formulation, etc.--all "well before" biosimilars from the likes of Amgen and Novartis enter the U.S. market, he wrote to clients over the summer.
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