Biosimilars

The biosimilar pack is growing around Roche’s all-star trio, looking to rip into a $21B franchise

Roche will get another reminder this week about just how important its late-stage pipeline is these days.

Thursday, the FDA’s committee of outside cancer experts will field a pair of applications for two new biosimilars of Avastin and Herceptin, two longtime drug franchises that last year provided about $14 billion in revenue to the Swiss pharma giant. And according to the FDA insiders who did the internal reviews, both of these copycats are ready to go.

The vote, highly predictive of a likely approval to come — unless these manufacturers get hit with a surprise rejection on manufacturing issues, like Pfizer did recently — comes just weeks after Novartis lined up a European approval for a biosimilar of Rituxan, a $7.5 billion player at Roche. That was the second European OK for a Rituxan copy, following Celltrion’s win.

Biosimilar competition is not the same as generics in small molecules. Without an onslaught of rivals, the initial discounts are smaller. But Roche knows their numbers on these drugs can only go down as competition heats up.

In their place, it’s been fielding new potential blockbusters, like Tecentriq, troubled by a recent Phase III failure. Ocrevus is expected to make a major addition. Roche also has added reasons to hope for a success with new drugs like emicizumab for hemophilia, which Shire has now targeted in a legal onslaught aimed at scuttling the threat to its own drugs in the field.

Now here come two more biosimilars to Roche therapies, and there isn’t much doubt about how things will play out tomorrow.

First up: ABP 215 from Amgen, a copycat of Avastin. Not much doubt where the agency is coming from here.

The totality of evidence from the ABP 215 biosimilar development program leads to the conclusion that ABP 215 meets the scientific and statutory requirements for the demonstration of biosimilarity. Specifically, ABP 215 is highly analytically similar to bevacizumab notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between ABP 215 and bevacizumab in terms of PK, efficacy, safety, and immunogenicity.

Second up: MYL-14010 from Mylan, a Herceptin knockoff. Also evidently a shoe-in.

The totality of analytical data support the determination that MYL-1401O is highly similar to USHerceptin notwithstanding minor differences in clinically inactive components. In addition, the scientific bridge between EU-Herceptin, US-Herceptin, and MYL-1401O was established, supporting the use of nonclinical and clinical data generated with EU-Herceptin to support a demonstration of biosimilarity of MYL-1401O to US-Herceptin.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017