Biosimilars Deals 2021

Significant biosimilar activities this week include

22 Oct 20 | Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced recruiting in Poland.

26 Oct 20 | Samsung Bioepis announced results from two post-marketing studies of Renflexis® (biosimilar infliximab) in Veteran Affairs patients with IBD. The first study evaluated the safety of switching from reference infliximab to Renflexis®, finding that patients who were on reference product or biosimilar infliximab can remain stable after switching to another biosimilar without major safety concerns. The second study looked at utilisation patterns of infliximab for IBD, finding that the uptake of Samsung Bioepis’ Renflexis® (following its listing as the preferred product on the Veterans Affairs National Formulary Policy) was faster than the adoption of the previous biosimilar listed in the year prior.

27 Oct 20 | Alvotech announced that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million round, with a second round expected to close shortly. The new share issue values Alvotech at $1.5 billion.

28 Oct 20 | Amgen released its Q3 2020 financial results. Amgen reported an 11%  year-over-year increase in sales of Prolia® (denosumab), a 3% year-over-year decrease in Enbrel® (etanercept) sales, a 31% increase year-on-year of  Amgevita® (biosimilar adalimumab) sales, 34% increase quarter-to-quarter of Mvasi® (biosimilar bevacizumab) sales, 36% increase quarter-to-quarter of Kanjinti® (biosimilar trastuzumab) sales, 22% decrease year-over-year of Neupogen® (pegfilgrastim) sales, 20% increase year-over-year of Neulasta® (filgrastim) sales and a 15% decrease in year-over-year sales of Aranesp® (darbepoetin alfa). Amgen also announced that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

28 Oct 20 | Pfizer released its Q3 2020 financial results. Pfizer reported an 80% increase in revenues for biosimilars, attributed to launches of Ruxience® (biosimilar rituximab), Zirabev® (biosimilar bevacizumab) and Trazimera® (biosimilar trastuzumab), and continued growth from Retacrit® (biosimilar epoetin zeta). Pfizer reported that revenues for Enbrel® (etanercept) declined 21%, reflecting continued biosimilar competition in most EU markets, Japan and Brazil.

29 Oct 20 | US: SomaLogic announced it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year collaboration will streamline the development of biosimilars by reducing the need for comparative clinical studies, thus accelerating the delivery of safe, effective and affordable biosimilar treatments.

30 Oct 20 | Ocumension Therapeutics announced it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

30 Oct 20 | AU: Australia’s PBAC published its list of subsequent decisions not to recommend arising from its July 2020 meeting. Among the rejections were Roche’s submission for Ocrevus® (ocrelizumab) relating to a proposed new indication for primary progressive multiple sclerosis, Novartis’ application for PBS listing for Beovu® (brolucizumab), and GlaxoSmithKline’s application for PBS listing for Benlysta® (belimumab).

Significant biosimilar activities this week include

15 Oct 20 | Henlius and Essex announced they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally.  Essex will be responsible for 80% of the costs and expenses in relation to the development of HLX04. Henlius is entitled to milestone payments of up to US$43 million, as well as royalties of up to 10% of annual net sales of the product.

20 Oct 20 | NeuClone announced its proposed ustekinumab biosimilar has successfully met all primary and secondary endpoints in Ph I clinical trials. Noelle Sundstrom, CEO of NeuClone announced that the company plans to enter Ph III trials in 2021.  The product is being jointly developed by NeuClone and the Serum Institute of India.

20 Oct 20 | Daily News Egypt announced Sandoz Egypt has partnered with the Egyptian Cancer Society to launch a rituximab biosimilar in Egypt. Sameh Elbagoury, Sandoz Country Head for Sandoz Egypt and Libya, announced that the biosimilar could reduce the cost of treating Non-Hodgkin Lymphoma by 40%.

20 Oct 20 | The American Journal of Managed Care reported a new study indicates Celltrion’s rituximab biosimilar CT-P10 could lower costs and expand patient access to biologic therapy for primary Sjogren syndrome.

21 Oct 20 | Biogen released its Q3 2020 results, reporting a 7% increase in revenue of Benepali® (biosimilar etanercept), 14% increase in revenue of Imraldi® (biosimilar adalimumab), and 49% increase in revenue of Flixabi® (infliximab) compared to the same quarter last year.