Roche sets up patent hurdle for Bioepis' Herceptin biosimilar: analyst

Gavel and flag in courtroom
Roche has reportedly sued Biogen and Samsung over the Herceptin biosimilar they hope to get approved in December. (Getty/AlexStar)

Roche is battling competition from Herceptin biosimilars to the bitter end. The Swiss drugmaker has sued Bioepis over its biosimilar as it heads for the finish line, Bernstein analyst Ronny Gal reports.

Bioepis partners Biogen and Samsung are looking for a December approval of their candidate after resubmitting their BLA in June. But Gal said in a note to investors today that Roche has sued the JV over 21 patents, which the two sides agreed should be in contention after a truncated information exchange. He said the suit mainly concerns secondary patents.

Roche sued Pfizer last year over 40 patents on its Herceptin biosimilar, and Mylan has settled with Roche for a mid-2019 launch. But drugmakers are anxious for a cut of the sales of Roche’s second-best-selling drug, with $7.2 billion in worldwide sales and $2.7 billion in the U.S. last year.

“We wonder how long Pfizer and BioEpis will wait before being willing to launch at risk, but 1/1/2019 entry looks unlikely, in our view,” Gal wrote to investors today. Roche and Biogen both declined to comment for this story.

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Drugmakers are closing in on Roche’s global cancer fortunes. Bioepis’ Ontruzant already won approval in Europe last year and was launched in May by Merck & Co., which has marketing rights to the biosimilar there. Also last year, Amgen and Allergan won U.S. approval for Mvasi, an Avastin biosim approved in each of the branded drug’s indications. Amgen and Allergan’s approval represents the first cancer biosim nod in the U.S. and a threat to $3 billion in Roche sales in the States.

Gal points out in his note that Roche’s Cabilly patents also expire this year. For nearly 35 years, the so-called Cabilly patents, granted to Roche’s Genentech unit in 1983, have allowed Roche to set up a toll booth collecting royalties from competitors including Eli Lilly, GlaxoSmithKline and AbbVie, which uses the processes to manufacture Humira, the world’s global leader with $16 billion in sales.

Those patents expire in December 2018, a year in which these patents are estimated to generate about $1 billion for Roche and City of Hope, where a team led by scientist Shmuel Cabilly, Ph.D., first developed the manufacturing process.