Biosimilars

The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.

Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

Stada has appointed former Biogen biosimilars head Ian Henshaw as the new leader of its Specialty segment. Meanwhile, Craig Burton has left the AAM for Fresenius Kabi, Australia's GBMA is looking for a new chief executive, and Speranza, Outlook and EuroAPI have announced new appointments.

A third pair of Prolia and Xgeva rivals has now been launched in the US, with Celltrion throwing its hat into the ring after denosumab launches by Sandoz and Fresenius Kabi. But this is only the beginning for what is shaping up to be another highly competitive biosimilars market.

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

Bio Usawa’s CEO said access to advanced biologics should not be a privilege of geography or income, as it prepares to launch Formycon/Bioeq’s ranibizumab biosimilar in Africa.

Sandoz has begun constructing a major biosimilars manufacturing facility in Slovenia that is set to become operational in 2028. A $440m investment in the project adds to local biosimilars initiatives that together total over $1bn, helping Sandoz to move out of the shadow of former parent Novartis.

As Biocon Biologics picks up the latest approvals in Europe for its Stelara biosimilar, Blake Leitch, the firm’s head of Europe, talks to Generics Bulletin about what lies ahead for Biocon and for biosimilars more widely in the region – including tackling the “biosimilar void”.

Fresenius Kabi has become the second company to launch US denosumab biosimilars, taking its current biosimilars portfolio up to six products.

With the August 1 deadline looming for entries to the Global Generics & Biosimilars Awards 2025, contenders have just one month left to submit their achievements.

A proposed biosimilar to one of the lesser spoken about monoclonal antibodies for inflammatory conditions, UCB Pharma’s Cimzia, is the latest candidate to join the significant commercial partnership between Alvotech and Advanz Pharma.

Canada will welcome its first Eylea off-patent rival in July, as Biocon Biologics celebrates the commercialization of its 10th biosimilar worldwide.