AbbVie loses a round in the heavyweight biosimilar fight over Humira patents

Few drugs attract the kind of attention from the biosimilars crowd that Humira warrants. AbbVie gets the lion’s share of its revenue from this $16 billion behemoth and the biopharma company has sworn to guard its patents with a legion of the best paid attorneys in the field.

But the generics crowd continues to chip away at its IP foundation.

On Tuesday Coherus BioScience scored a key win in its ongoing battle to market a knockoff. The US Patent and Trademark Office’s Patent Trial and Appeals Board ruled in its favor on one of a set of patents, for ‘135, triggering an 8% surge in its share price $CHRS and a 2.3% drop for AbbVie $ABBV.

Geoffrey Porges, Leerink

What’s it mean?

Leerink’s Geoffrey Porges looked it over and concluded that Coherus or Boehringer Ingelheim just may get to start marketing their biosimilar in 2019 instead of the consensus estimate of 2020. And that’s a big deal that could accelerate development efforts on a copycat that could pass muster on the patent side. But it won’t be easy.

His comment:

To be clear, the hurdle for any biosimilar company to launch a biosimilar-Humira by 2019 is still high, and given AbbVie’s extensive patent estate extending into the 2030’s, any biosimilar challenger must be willing to undertake an at-risk launch until further patents are invalidated through the IPR process or the Federal Circuit Courts. However, removing the dosing patent opens the door for a fast-to-market approach with biosimilar formulations that do not infringe AbbVie’s 14+ formulation patents, of which Coherus has publicly disclosed development. The strategies of these challengers (and the ongoing 180-day launch notice US Supreme Court case) still have significant impact on the legitimacy of Coherus’ program, but we expect the market to price in a worst-case 2019E biosimilar launch after this ‘135 decision.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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