Blog Big Molecule Watch March 20, 2020

Biosimilars Development Updates: Mylan’s Pipeline, Coherus’s Adalimumab aBLA, Amgen’s Eculizumab Biosimilar

Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely getting to the market in this year.” Mr. Malik also indicated that biosimilars of “molecules like Orencia, Prolia and Stelara” are “in very early stage” development by Mylan, and that Mylan has extended its relationship with Biocon to include biosimilars of Perjeta and Toujeo. Mylan’s CEO, Heather Bresch, addressed the matter of the coronavirus and noted that although Mylan’s “business exposure is limited…, given the global nature of our supply chain operations and businesses, our results could potentially be impacted.” Ms. Bresch noted that Mylan is continuing to monitor the situation closely from a business perspective.

Coherus recently provided an update on its projected timeline for filing its aBLA for is adalimumab biosimilar. As we previously reported, Coherus entered into a settlement agreement with AbbVie last year under which Coherus was granted a global, non-excusive, royalty-bearing license under Abbvie’s patents to commercialize CHS-1420, its proposed adalimumab biosimilar beginning in late 2023. Coherus expects to file its adalimumab aBLA in the second half of 2020. On their quarterly earnings call last month, Dennis Lanfear, Chief Executive Officer of Coherus noted that Coherus has held a series of Type-3 meetings with FDA over the past year and “have now gained concurrence with FDA on the analytical and clinical strategy in support of the BLA filing in the second half of 2020.”

According to Amgen’s Head of R&D, David Reese, Amgen is initiating phase 3 clinical trials of its eculizumab biosimilar. In the company’s quarterly earnings call at the end of January, Mr. Reese indicated that Amgen is actively enrolling patients in its Phase 3 clinical study for ABP 959, its biosimilar product for Soliris.

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