Biosimilars

Gedeon Richter and Bio-Thera Solutions have announced a European licensing deal worth potentially more than $100m for the Chinese biosimilar developer’s BAT2206 proposed rival to Stelara.

Partners Dong-A ST and Meiji Seika Pharma have demonstrated their credentials in the US biosimilar market, bagging a US Food and Drug Administration approval for their biosimilar Stelara product that will be commercialized by Accord Healthcare.

Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.

Sandoz, Adalvo and Eurofarma were the biggest winners at the Global Generics & Biosimilars Awards 2024, each taking multiple honors, among the many champions named across 14 separate categories at our prizegiving ceremony in Milan.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.

Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen’s Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials.

As broad stock markets finished the third quarter of 2024 on a high, two large biotech companies battled on more than one front. Despite both announcing positive news in the last week of the quarter, neither seemed to be a clear winner over that period.

Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.

Teva is continuing along its well-trodden path of partnered biosimilar assets, striking a further agreement with Spanish develop mAbxience that could be for the development of either pembrolizumab or nivolumab.

Aeon Biopharma has heralded its latest interaction with the US FDA over its planned Botox biosimilar as a win that sets the stage for analytical studies, trials and a subsequent filing.