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Biosimilars will leave a $10B gap in Roche’s sales, but new drugs can more than fill it: exec

September 18, 2019
Life sciences

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Roche’s trio of legacy cancer megablockbusters face an unclear path forward as biosimilars hit or near the U.S. market. By the drugmaker’s own math, Herceptin, Avastin and Rituxan will indeed leave a big dent in its sales—an almost $10 billion dent, in fact.

But Roche execs have said growth from newer drugs will be more than enough to fill that hole, and Monday, they offered up some numbers to illustrate the point.

Assuming 60% to 70% “conservative” erosion from biosims, Roche could be looking at a sales gap of CHF 9.6 billion ($9.6 billion) between 2018 and 2023, Roche pharma chief Bill Anderson said at an investor event Monday. But worry not, he added: Consensus on the Street figures that by 2023, the company’s recent launches and pipeline could turn up an additional CHF 16.3 billion.

Still, both the erosion from biosims and enthusiasm about up-and-comers are big “ifs.”

The CHF 9.6 billion gap is based on assumptions that Perjeta and Kadcyla could flatten out Roche’s entire HER2 franchise despite Herceptin’s decline, and that Avastin’s and Rituxan’s combined CHF 13.6 billion sales in 2018 will crash to merely CHF 4 billion by 2023.

Anderson said it’s still too early into rival launches to assess the impact, but he admitted the U.S. biosim market can be hard to quantify. Amgen and Allergan launched U.S. biosims to Herceptin and Avastin in July, and Teva and Celltrion’s Rituxan copy could debut later this year.

The company expects biosims to chip away sales more slowly in the U.S. than in the E.U. because the U.S. biosimilar market still hasn’t found its feet. Previous biologic copycats have been slow to catch on, he said. But using either benchmark—European rollouts or previous U.S. launches—can be dangerous.

“There have only been a handful of biosimilars that have launched in the U.S., and most of those have launched against originator products that were either no longer the standard of care or already somewhat commoditized and have high levels of discounting and contracting,” but the three Roche products are none of those, he said.

“Some people would look at the biosimilar situation in the U.S. in some other […] disease areas and say ‘The biosimilars aren’t really taking off at all, maybe it’ll be the same for Genentech.’ I think we don’t see it that way,” he added. “We think we will have a significant depletion of our sales over the next three to four years.”

A team of analysts at ODDO BHF, for one, projected a more aggressive biosim hit of about CHF 13 billion in lost sales, according to a Tuesday note. Analyst consensus, ODDO figures, is about CHF 10.5 billion.

Meanwhile, leading the pack of new growth drivers is Ocrevus, the multiple sclerosis drug that’s been crowned “the most successful launch in the history of Roche.” It alone could add an additional CHF 3.8 billion to Roche’s top line in 2023 compared with 2018.

In the first half of 2019, Ocrevus grew sales by 63% to CHF 1.7 billion, and it has gradually grown its U.S. new patient starts to about 40% despite the recent launches of Novartis’ Mayzent and Merck KGaA’s Mavenclad. But a new drug’s lurking around the corner.

Novartis just showed its ofatumumab (sold under the brand Arzerra in leukemia) topped Sanofi’s Aubagio at reducing relapse rates and cutting the risk of disability progression, as well as brain lesions and inflammation, according to data presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting last week.

But Teresa Graham, Roche Pharma’s head of global product strategy, played down the drug’s potential threat because Ocrevus has more consistent and longer-term data.

Ocrevus itself just showed it could significantly reduce the risk of permanent disability or disease progression in primary progressive MS patients who had taken the drug for more than six years.

“Coming off of ECTRIMS, where competitive data were presented, it’s important to remember the strength of our data across all key endpoints, from controlling relapses to long-term control of disease progression, across all trials, which reinforces our belief that deep B cell depletion really matters in controlling the disease,” she told investors during the Monday event.

Both Ocrevus and Arzerra are anti-CD20 antibodies that work by depleting B cells. Arzerra comes as a once-monthly injection, while Ocrevus is given six months apart.

Also in Roche’s CNS offering is spinal muscular atrophy therapy risdiplam, for which a filing is expected this year. The company is targeting SMA types 1/2/3 from the get-go. If approved, it could be the first oral therapy for the disease and will go against Novartis’ gene therapy Zolgensma.

Speaking of novel platforms, Roche seemed to reject cell therapies until perhaps its pact with Adaptive Biotechnologics early this year. But Anderson pointed to Roche’s recently launched lymphoma drug Polivy as part of its range of blood cancer offerings, which ODDO’s analysts pegged as one of the company’s major opportunities alongside CNS.

Roche never said cell-based therapy is never relevant, Anderson said. “We simply were looking at basically what was on offer at the time and think we can do better than that,” he said.

Polivy, approved by the FDA just in June, is seeing uptake about five times faster than CAR-T treatments in the same diffuse large B-cell lymphoma setting, according to Anderson. Roche expects the drug to contribute $900 million in sales by 2023.

ODDO’s optimism comes bigger than that, though. “More than the undervaluation of a compound, our takeaway is a strong rationale in the division’s development with clinical synergies likely to lead on to commercial synergies,” the analysts said.

By Angus Liu

Source: Fierce Pharma

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