Biosimilars, Legal

Pfizer’s latest copycat could put the squeeze on Roche — again

Pfizer $PFE is barreling forward on its plans to recreate Roche’s stalwart cancer drugs, announcing positive data this morning for its Rituxan copycat called PF-05280586. Considering Roche’s $RHHBY recent backlash to biosimilar competition, it’s possible that Pfizer will continue to poke the rather litigious bear.

Like you’d want to see from a biosimilar, PF-05280586’s trial met its primary endpoint and showed equivalence in overall response rate for patients with CD20-positive follicular lymphoma.

Amrit Ray

“These results reinforce the potential of our proposed rituximab biosimilar in providing a safe and effective treatment option for patients,” said Pfizer’s R&D president Amrit Ray in a statement.

Considering its loss of patent protections for core brands like Lipitor and Viagra, investing in biosimilars is a growth strategy for Pfizer. Biosimilars, a purported $10 billion to $30 billion global market opportunity, is the company’s new target.

Years ago, Pfizer got FDA approval for Inflectra, its knockoff of J&J’s Remicade. Now it’s taking on Roche’s cancer portfolio: Herceptin, Avastin, and Rituxan. That’s largely due to the company’s 2015 acquisition of Hospira, which was developing biosimilars for those drugs. US sales for these biologics was around $9.5 billion in 2016. Since copycats are priced 20% under, some have speculated that Pfizer is looking at a $7.5 billion addressable market.

But as Pfizer puts the squeeze on Roche and J&J’s revenue, these drugmakers are fighting back.

Roche launched a legal battle against Pfizer for its Herceptin copycat, alleging Pfizer had infringed on 40 of Roche’s patents. The backlash makes sense. Herceptin sales makes up a big chunk of the Roches’s total revenue, bringing in about $2.5 billion in sales last year (or 5% of total revenue).

J&J, on the other hand, has made deep cost cuts to Remicade to keep Pfizer’s rival biosimilar at bay. Pfizer sued J&J alleging the company was using “exclusionary contracts” that barred Pfizer from reaching most patients. Pfizer got some good news on that battle front earlier this week, as a US appeals court upheld a ruling that invalidated a key patent for Remicade.

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Biotech Investment Analyst
SV Health Investors Boston, MA
Director, Program Management
Contrafect Corporation New York, NY
Director, Translational Sciences
Cadent Therapeutics Cambridge, MA

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