DEAL WATCH: Biosimilars, Biosimilars and More Biosimilars

It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced.

First, on November 4, Henlius and Ascentage Pharma announced that they entered into a collaboration to conduct clinical trials of the combination therapy for oncology using Henlius’s rituximab biosimilar, HLX01, which was approved and launched in China earlier this year, and Ascentage’s APG-2575, a proprietary orally administered Bcl-2 selective inhibitor.

Also on November 4, Alvotech announced that it has entered into an exclusive partnership with investment group Yas Holding for the Middle East and North Africa that will provide Yas with supplies to commercialize three Alvotech biosimilar candidates in this region.  According to the press release, Yas has acquired a 2.5% stake in Alvotech, and the total partnership value is estimated to be around $45 million.

Alvotech further announced yesterday that it has entered into a collaboration with STADA under which STADA will exclusively commercialize seven of Alvotech’s biosimilar products in key European markets and certain markets outside of Europe. The companies’ joint press release does not specify which biosimilars are encompassed by the deal, but indicates that “the initial pipeline contains biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions as well as ophthalmology for patients around the world” and that the “originator products of the seven biosimilars currently generate $50 billion in sales globally.”

Yesterday, Bioeq and Coherus announced that they entered into a license and development agreement under which Coherus will exclusively market and distribute Bioeq’s biosimilar candidate to LUCENTIS (ranibizumab) in the United States. The companies indicate that Bioeq will be responsible for submitting the aBLA to the FDA in the fourth quarter of 2019 and for subsequent product supply, and that Coherus plans to launch the product in 2021. Bioeq further stated that “starting in 2020, Bioeq will also be in a position to offer rights for its biosimilar ranibizumab to marketing and distribution partners outside the U.S.” Bioeq, a joint venture between the Polpharma Biologics Group and the Strüngmann Group, co-developed FYB201 with Formycon.

Biogen and Samsung Bioepis also announced yesterday that they entered into a new commercialization agreement covering the United States, Canada, Europe, Japan, and Australia for two biosimilar candidates under development by Samsung Bioepis: SB11, a biosimilar candidate of LUCENTIS (ranibizumab) that is undergoing phase 3 clinical trials; and SB15, a pre-clinical biosimilar candidate referencing EYLEA (aflibercept). The companies also indicate that the agreement gives Biogen the option to extend the commercialization term for Samsung Bioepis’s three anti-TNF biosimilar—BENEPALI (etanercept), FLIXABI (infliximab), and IMRALDI (adalimumab)—in Europe for additional five years beyond the original ten-year agreement, as well as exclusive commercialization rights to these three biosimilar in China.

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