Biosimilar and Follow-on Biologic Development Updates

Below are some highlights of recent news in biosimilar and follow-on biologic development:

On June 14, Sandoz announced positive clinical study data regarding HYRIMOZ, its biosimilar of HUMIRA (adalimumab). According to Sandoz’s press release, data from a 48-week phase 3 clinical study demonstrated that switching from HUMIRA to HYRIMOZ provides sustained efficacy with no new safety concerns in patients with moderate-to-severe rheumatoid arthritis with inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX). Sandoz states that the study successfully met its primary and secondary endpoints and showed that the efficacy and safety of HYRIMOZ matches that of HUMIRA with no clinically meaningful differences in the studied patient population. Sandoz began to commercially market HYRIMOZ in Europe this past October, but has agreed to hold off on launching this FDA-approved biosimilar in the United States until September 30, 2023, under the terms of a settlement agreement.

On June 3, Alvotech and Abdi Ibrahim announced that they had entered into an exclusive partnership for the manufacturing and commercialization of Alvotech’s biosimilar portfolio for the Turkish market. According to the joint press release, “Alvotech will be responsible for the development and joint supply of multiple high value biosimilar assets from its current product pipeline, while Abdi Ibrahim will be responsible for joint manufacturing from its own facility, along with the registration and commercialization of these assets in Turkey.”

Also on June 3, Outlook Therapeutics (formerly known as Oncobiologics) announced that it entered into a master services agreement with FUJIFILM Diosynth Biotechnologies (FDB) for the production of ONS-5010, Outlook’s proprietary ophthalmic bevacizumab product candidate for the treatment of wet age related macular degeneration (wet AMD) and other retinal diseases. Outlook states that “under the terms of this agreement, FDB will provide global manufacturing of ONS-5010 to Outlook in support of the commercialization strategy for the drug.” Outlook is not pursuing ONS-5010, which is currently in phase 3 clinical trials, as a biosimilar of AVASTIN (bevacizumab). Rather, according to the company’s website, “Because there are no approved bevacizumab products for the treatment of retinal diseases, we are developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.” If the clinical trials are successful, Outlook states they will support the company’s plan to submit a regulatory approval application for ONS-5010 in multiple markets in 2020.

On May 31, XBrane and STADA announced that they have expanded their strategic biosimilar development partnership from just Xlucane, a proposed biosimilar of LUCENTIS (ranibizumab), to two additional biosimilar candidates. The two additional products are Xcimzane, a proposed biosimilar of CIMZIA (certolizumab pegol), and Xdivane, a proposed biosimilar of OPDIVO (nivolumab). According to the companies’ joint press release, STADA and Xbrane will evaluate and negotiate a potential development and commercialization agreement around these products, up until initiation of the products’ clinical trials.  During this period of evaluation, STADA has a right of first refusal for a license of Xcimzane and Xdivane for Europe. The companies also state that “in the near future both companies will evaluate potential collaboration around the development and commercialization of additional biosimilars.”

On May 28, Prestige BioPharma announced that its Marketing Authorisation Application for HD201, a proposed biosimilar of HERCEPTIN (trastuzumab), had been accepted for review by the European Medicines Agency.  As we have previously reported, Prestige has entered into agreements with a number of companies to market HD201 around the world.