Biosimilars, Legal

Under pressure from copycats, Roche sues Pfizer over Herceptin rival

As biosimilar competition puts a squeeze on Roche’s revenue, the company is launching a legal battle against Pfizer and its copycat version of Herceptin, Roche’s breast cancer drug, in hopes to slow or squash a rival medicine.

Roche’s Genentech business is alleging that Pfizer’s $PFE copycat, called PF-05280014, infringes on 40 of Roche’s patents. In the suit, the Swiss pharma giant is asking for compensation on lost sales on Herceptin, should the copycat get approval before Roche’s patents expire.

It makes sense for Roche $RHHBY to be worried. Herceptin sales make up a big chunk of the company’s total revenue, bringing in about $2.5 billion in sales last year (or 5% of total revenue), Bloomberg reports. Roche’s three big revenue drivers in cancer are Rituxan, Avastin, and Herceptin — all of which face growing pressure from biosimilar competition. Roche said the rivals will start affecting its sales in 2018.

Daniel O’Day

The copycat competitors are particularly a problem for Roche in Europe, where biosimilars are coming to market way faster than in the US. While the US has only approved five biosimilars since Congress passed legislation allowing such copycats, Europe has approved 25. Just days ago, South Korean biotech Samsung Bioepsis Co. Ltd. got the OK from the European Commission to sell Ontruzant, a biosimilar referencing Herceptin, in Europe. It was the first Herceptin copycat (using trastuzumab antibody) approved in Europe so far. 

On a conference call in October, Roche’s CEO Daniel O’Day said biosimilars of Herceptin will start having an impact in Europe this quarter and into the coming year.

For more details on the recent lawsuit: Genentech v. Pfizer, 17-cv-1672, U.S. District Court, District of Delaware (Wilmington).



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