Companies continued to prove in October that rare regulatory approvals and a pandemic have not stopped them from moving forward with plans to further products and search for ways to save money.
Despite a low number of approvals throughout 2020, companies continued to push through by advancing clinical testing for new biosimilars, formulating deals to develop new products, and experimenting with ways to implement biosimilars as a cost-saving strategy.
Product Advancement Announcements
Early in the month, Centus Biotherapeutics said that the European Medicines Agency (EMA) had granted marketing authorization to the company’s bevacizumab biosimilar (Equidacent) for the treatment of several forms of cancer.
The biosimilar referencing Genentech’s Avastin received indications for cancers of the colon, rectum, breasts, lungs, kidneys, ovaries, fallopian tubes, the peritoneum, and the cervix.
Additionally, the EMA began reviewing Samsung Bioepis’ ranibizumab biosimilar (SB11) to treat retinal vascular disorders, a leading cause of blindness. The product, along with an aflibercept biosimilar, was developed as part of a commercialization partnership with Biogen, who will handle the marketing of SB11 in the United States, Japan, Europe, Canada, and Australia.
Celltrion Healthcare said that it intends to initiate a phase 3 trial for its omalizumab biosimilar (CT-P39) candidate for the treatment of chronic idiopathic urticaria after receiving a regulatory greenlight from the Republic of Korea’s Ministry of Food and Drug Safety.
Moreover, Celltrion also began a phase 3 trial for its monoclonal antibody treatment candidate (CT-P59) for the coronavirus disease 2019 (COVID-19). The trial will test the candidate in 1000 patients evaluate the prophylaxis capability of CT-P59 in patients exposed to SARS-CoV-2, the virus that causes COVID-19.
Around the same time, Alexion said that it had received FDA approval for a new formulation of its originator eculizumab (Soliris) follow-on product, ravulizumab (Ultomiris), to aid in the company’s mission to retain as much Soliris market share as possible when biosimilar versions eventually enter the market.
Accord Healthcare had a very busy start to the month with the launches of 2 oncology biosimilars, for pegfilgrastim (Pelgraz) and trastuzumab (Zercepac) and amended its agreement with Shanghai Henlius Biotech to allow Accord to have the commercialization rights for Zercepac in the United States and Canada.
Business Deals Announcements
In addition to having an expanded partnership with Accord, Henlius said that it would share distribution of its bevacizumab biosimilar candidate (HXLX04) with Zhuhai Essex and Essex Bio-Investment for the treatment of wet age-related macular degeneration.
The deal’s terms stated that Henlius would receive up-front and regulatory and commercial milestone payments of $43 million and cumulative payments of $30 million for every $1 billion in net sales above the first $600 million, which will aid in offsetting the costs of sublicensing fees and development costs.
Medicure and Reliance Life Sciences (RLS) entered into agreement to market 1 unnamed cardiovascular biosimilar. As part of the deal, Medicure will have exclusive commercialization rights in the United States, Canada, and the European Union. RLS, based in Navi Mumbai, India, currently has no FDA-approved biosimilars; however, a 2018 analysis of the company showed that it has 14 biosimilars in its pipeline.
Other Business News
Additionally, Alvotech reported that it had invested $65 million in its parent company Alvotech Holdings to further ongoing development of biosimilar candidates. Alvotech currently has a biosimilar pipeline featuring molecules used to treat several autoimmune diseases, cancer, and inflammatory conditions.
Lastly, an experiment by Dean Foods to implement a health plan carve-out on drugs on both the medical and pharmacy side yield a cost savings of $174,600 (77% reduction) by switching employees from a select number of originator products to lower-cost biosimilars, according to a report. Spending on 4 biosimilars in 2019 was well below what the company would have spent on the 3 originator products, amounting to just $52,900 instead of $227,500.