US Biosimilars: Busting Blockbusters Or Managing Obsolescence?

As a new generation of biosimilars challenge some of pharma’s biggest-selling products, this In Vivo analysis looks at how the originator blockbuster might fare in the face of competition. Experience in Europe, which predates that in the US by about a decade, provides a number of crucial pointers to outcomes and defensive strategies.

US Biosimilars

The stage is now set for an attritional war in biologics in the US. The US Congress may decide to pull back from the Affordable Care Act, but the regulatory pathway for biosimilars in the US is very likely to remain intact. In recent months, the FDA has approved or progressed biologics license applications from a number of biosimilar developers both in the US and outside for products that reference several of the world’s biggest selling biologics. These include biosimilars that challenge biologics with current (2016) global sales in excess of $50 billion, including Amgen Inc./Pfizer Inc.'s Enbrel (eterancept), Johnson & Johnson's Remicade (infliximab), Roche's Herceptin (trastuzumab) and at the top of the pile, Abbvie Inc.'s Humira(adalumimab). (See Exhibit 1.)

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