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.

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.

Organon and Henlius have marked progress on their partnered HLX11 pertuzumab candidate, with the proposed biosimilar to Perjeta meeting the primary endpoint in a Phase III trial.

Generics Bulletin previews the most notable and anticipated events for October 2024.

Fresenius and Formycon have celebrated simultaneous US and EU approvals for the firms’ partnered Otulfi ustekinumab rival to Stelara. And with competing biosimilars already available on the European market, all eyes will soon be on US launches at the start of 2025, with Fresenius providing a significant update on launch timing.

Xbrane says scientific advice from the US FDA on a “streamlined” clinical program for its proposed nivolumab biosimilar, comprising just a single trial, will cut the development costs and timeline for the Opdivo rival, making it more attractive as Xbrane seeks a commercialization partner.

Generics Bulletin recaps the most recent regulatory news from across the world.

As it announced the start of trials for its AVT16 proposed rival to Takeda’s Entyvio, Alvotech reiterated that it is one of just two publicly-disclosed biosimilar developers targeting vedolizumab.

Fresh leadership has been announced for the US Association for Accessible Medicines, with new president and CEO John Murphy joining the generics and biosimilars organization after serving in key roles at brand industry associations PhRMA and BIO.

Following the FDA’s approval of A 150mg version of Accord’ Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.

Amgen has broken away from the pack of other US biosimilar challengers to Eylea in the US, by avoiding an injunction requested by originator Regeneron that would block the launch of its aflibercept rival. However, with litigation ongoing, any launch would be at risk.

The Unified Patent Court is beginning to see its first actions involving pharmaceutical patents. In a case brought before the court that sought to put a leash on Celltrion’s EU-approved biosimilar to Novartis/Genentech’s Xolair (omalizumab), the court sided with the Korean firm.

In the wake of Biocon’s debut positive opinion for an aflibercept rival to Eylea just over a year ago, two further companies – Sandoz and Samsung Bioepis – have now secured coveted endorsements from the European Medicines Agency for their own versions of the ophthalmic biosimilar. Meanwhile, Teva has received a CHMP nod for another Imnovid generic.