Approvals

ANI’s generic division and rare disease business have both led to a boost in net revenue for the past quarter and in forecasts for the coming year.

While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.

After receiving an approval for the Neulasta rival in the US in May 2022, Kashiv BioSciences has now added a further North American country with a positive nod from Canada’s health agency.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.

Leqembi is finally on track for approval by the summer, though safety precautions mean fewer patients will be eligible for treatment than in the US, and its uptake is not expected to be strong.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Formycon has celebrated receiving a UK approval for its Ahzantive biosimilar version of Eylea, setting up a launch from partner Teva – which has already seen success in the UK market with the partners’ Lucentis biosimilar, Ongavia.