Wave Of Launches Boosts US Biosimilars Market
Range Of Discounts Seen As Multiple Competitors Face Off
A flurry of US biosimilar launches over the past few months has opened several molecules to true, multi-source competition, with a range of pricing strategies seen from competitors. However, some brands that already face biosimilar competition elsewhere in the world are still poised to enjoy a significant period of exclusivity in the US, such as AbbVie’s Humira.
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A wave of recent biosimilar launches in the US has provided multi-source competition on several major brands and stands to boost the country’s biosimilars market, according to Sean McGowan, senior director of biosimilars at AmerisourceBergen.
Assertions that the US should give up on supporting biosimilars in favor of controlling prices of off-patent biologic brands fail to recognize promising signs of progress, argues Richard Saynor, who has just taken over as CEO of biosimilars pioneer Sandoz.
In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.