Biosimilars: Improving Patient Access To Biologics While Bending The Cost Curve
Zarxio is the first in an expected wave of US biosimilar approvals as blockbuster originator biologics go off patent. Just as market competition for small molecules has proven to be healthy for both generics and brand-name biopharmas, competition for biologics will likely have similar effects.
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With two biosimilars set to move into Phase III this year, Oncobiologics hopes partnership with hospital services firm Premier will generate 'best practices around the optimal use of these cost-effective treatments.'
This year will be one of reckoning for US biosimilars: the four known submissions to the FDA’s biosimilar pathway will between them stress test all aspects of the regulatory framework. The coming months will determine how far FDA can go in support of biosimilars – and how far innovators are prepared go in defense of their portfolios.
Physicians appear more willing to prescribe Hospira’s Inflectra, a biosimilar version of J&J’s Remicade, to new patients in countries in Europe where it is available, but less inclined to switch patients already taking the brand. The company’s experience in Europe could offer lessons for manufacturers looking to bring biosimilars to market in the US.