Pharma, R&D

Teva hands Celltrion $160M to grab US rights on two biosimilars of Roche blockbusters

Teva is expanding its pipeline of biosimilars. The Israeli pharma company agreed to hand over $160 million to partner with Korea’s Celltrion on copycat versions of Herceptin and Rituxan, two of Roche’s biggest franchise drugs.

Teva, which can get $60 million of that back in the event of an unexpected setback, is grabbing US and Canadian rights to these two knockoffs. Combined, those two drugs earn $6.5 billion a year in the two countries. Obviously the lion’s share of the cash lies in the US. And the two companies’ deal includes a profit-sharing provision.

Both of these programs have wrapped with late-stage data. The Rituxan biosimilar, CT-P10, was submitted in Europe last year while the Herceptin generic CT-P6 is headed for a near-term arrival.

Biosimilars were slow to arrive in the US, but manufacturers have been making up for lost time with a string of new approvals this year. The brand name manufacturers, though, are typically turning to the courts looking to engage in a rear-guard defense of some of their most lucrative franchise drugs.

Roche, however, may not be able to hold back the looming Rituxan showdown beyond this year, leaving its third biggest blockbuster vulnerable to generic competition.

Just days ago Samsung Bioepis, partnered with Biogen, submitted their biosimilar of Herceptin for review in Europe, which has led the way with getting these discounted drugs on the market. And just before that investigators for Amgen and Allergan reported that ABP 980 was virtually indistinguishable from Roche’s Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer in a Phase III trial.

Novartis’ Sandoz, meanwhile, has been going after approvals for their Rituxan knockoff as well.

As these new drugs enter the market, the focus will quickly shift to what they’re selling for. The first one or two competitors aren’t likely to go for a deep discount, but once a multitude hit, Novartis CEO Joe Jimenez believes these drugs will sell for 25% of the price of the brand.

“Following on the heels of our global success with Remsima (Inflectra), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven record of quality, efficacy and safety to the reference product, we are confident that we will be able to repeat the same success in the U.S and Canada with CT-P10 and CT-P6 through our partnership with Teva,” said Celltrion CEO HyoungKi Kim.

Teva had a collaboration on biosimilar development with Lonza at one point, but scrapped the deal in 2013. CSO Michael Haydn, though, made it clear at the time that Teva would continue to partner opportunistically as it looked at near-term patent expirations as well as those lying from 2020 and beyond.

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