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biosimilars

Focus on Biologics
Katherine T. Adams

The implementation of the Affordable Care Act is expected to push the FDA into issuing a final rule, and several states have already considered the issue of biologic substitution. The cost advantage is incontrovertible, but will doctors and patients join reference product manufacturers in trying to restrict them?

Contributing Voices
Neil Minkoff, MD

Amgen is making a huge bet on biosimilars and helping to define the market.

The company announced that it is targeting 6 biotech blockbusters and will start selling them as  biosimilars in 2017. The initial targets: Avastin, Herceptin, Rituxan, Erbitux, Humira and Remicade. That’s over $40 billion in product. Even a small savings, like 15% to 20%, would result in a huge change in premiums.

It is still unclear what hurdles will need to be cleared from the FDA and/or other regulatory bodies, but a few other things have become very clear: