Pfizer's Herceptin biosim posts 'encouraging' phase 3 data in blockbuster sales battle

Pfizer is working to target Roche's Herceptin with a potential biosimilar of its own.

With positive results reported Wednesday, Pfizer has moved one step closer to challenging Roche’s breast cancer med Herceptin in a biosim contest with billions at stake.

Pfizer’s candidate, PF-05280014, demonstrated equivalence to Herceptin after 25 weeks of treatment in first line patients with HER2-positive metastatic breast cancer, the New York pharma reported.

Even as Pfizer advances its own biosim prospect, it trails Mylan and Biocon, which are also fervently seeking a piece of Herceptin’s $6.8 billion in annual sales. Earlier this month, the partners submitted an application for their biosim candidate to the FDA, hoping to be the first to take a crack at the Roche blockbuster on the market.

But as that race develops in the U.S., Pfizer and its partner Celltrion already have marketing experience in Europe with another biosim, their version of Merck’s Remicade.

That copycat has been taking a toll on the branded revenue, dragging European sales down 26% in the most recent quarter. Pfizer is now gearing up to launch its Remicade biosim in the U.S. at a 15% discount to the brand’s wholesale acquisition cost.

Seeing considerable opportunity in the biosimilar field, Pfizer last year laid out $15 billion for Hospira and its development programs. Then, in June, the company made a $350 million biosim manufacturing investment in China. Pfizer additionally has biosim projects working to target Roche’s Rituxan and Avastin, AbbVie’s Humira and Amgen’s Epogen.

Pfizer Essential Health R&D head Sumant Ramachandra said Pfizer is the “leading global biosimilars company,” in a statement Wednesday, adding that it’s “encouraged” by the new Herceptin biosim data.

As Herceptin faces potential biosim threats, Roche has had some success advancing other meds, such as Tecentriq, now approved in bladder and lung cancer, and multiple sclerosis prospect ocrelizumab. Boasting an FDA fast track, ocrelizumab is the first to show it can be effective in the primary progressive form of the disease.