February 08, 2019

IAM Quotes Chris Loh on the U.S.’s First Biosimilar Patent Suit and Its Impact on the Pharma IP Landscape

1 min

On February 8, 2019, Chris Loh was quoted in an article in IAM about how the plot continues to thicken in the patent disputes surrounding the world’s best-selling drug, adalimumab, best known under the brand name "Humira." After becoming the latest biosimilar producer to settle litigation with the drug’s originator, AbbVie, Coherus BioSciences recently filed its own U.S. lawsuit against fellow imitator Amgen, which it accuses of infringing its adalimumab-related IP rights. The first example of a biosimilar vs. biosimilar patent dispute in the U.S., the lawsuit augurs a shift in pharmaceuticals IP dynamics that will disrupt the traditional innovator vs. generic paradigm. It also highlights a complex set of pitfalls and opportunities facing "imitators" of biologic drugs.

But there are also positive commercial reasons for biosimilar companies to develop and patent new formulations, indications, and methods of manufacturing and administration.

According to the article, one way of seeking to distinguish a product is to develop proprietary technology; others include seeking "interchangeability" status or employing "different marketing strategies."

Loh said, "There is also the possibility for biosimilars to establish themselves as 'bio-betters' by demonstrating greater efficacy."