Biosimilars Business Roundup: June 2022

June brought with it several updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

June brought with it a number of exciting updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.

Biosimilar Progress and Launches

Amneal Pharmaceuticals and Kashiv Biosciences started off the month with a bang as their joint pegfilgrastim biosimilar Fylnetra became the fifth pegfilgrastim biosimilar to be approved by the FDA. The approval marked Amneal’s third and Kashiv’s second US biosimilar approval for 2022, following the approvals of Releuko, a filgrastim biosimilar, and Alymsys, a bevacizumab biosimilar. The companies said that the US launch of Fylnetra is expected during the second half of the year.

Additionally, Samsung Bioepis and Biogen announced the US launch of Byooviz, the first biosimilar referencing Lucentis (ranibizumab) and the first ophthalmology biosimilar approved in the United States. Byooviz is now available to patients with neovascular age-related macular degeneration (wet AMD), diabetic macular edema, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion, or choroidal neovascularization.

Outside of the United States, STADA Arzneimittel and Alvotech launched their high-concentration, citrate-free biosimilar referencing Humira (adalimumab), Hukyndra, in some European markets. Hukyndra, also known as AVT02, is available in France, Germany, Finland, and Sweden, with launched in more European countries to come.

Company Deals and Updates

Alvotech continued to have a big month as public trading of shares for the pure-play biosimilars developer began. The public listing, which is part of the Nasdaq stock market, represented the largest debut on a US stock exchange by an Icelandic company.

Furthermore, Organon and Shanghai Henlius Biotech announced that they would enter into a new partnership for the development of a pertuzumab biosimilar referencing Perjeta and a denosumab biosimilar referencing Prolia (Xgeva). Organon will have the exclusive commercialization rights for the biosimilars in all countries except China, including Hong Kong, Macau, and Taiwan.

Sandoz used June as a jumping off point for its global biosimilar initiative, Act4Biosimilars, which will work to promote greater access and adoption of biosimilars in more than 30 countries by 2030. The news came just before the announcement that the application for Sandoz’ high-concentration, citrate-free adalimumab biosimilar was accepted for review in the European Union.

In regard to finances, Formycon’s quarterly earnings statement revealed the completed acquisition of 2 biosimilars, the commencement of development for 2 others, and some expected losses for the company. The acquisition was for an ustekinumab biosimilar and a ranibizumab biosimilar.

Financial Viability of Biosimilars

In addition to company updates, a financial evaluation study proposed a framework for aiding companies in making decisions on which biosimilar markets to target based on financial viability. The authors of the study said that selecting a candidate biosimilar requires careful analysis to ensure that their development efforts create value for the company.

The framework involved the use of the net present value model to assess financial viability of a molecular, which is a commonly used tool for assess the viability of an investment across different industries. The authors made a list of aspects that an effective framework should contain.