Sandoz takes purpose at Amgen’s Prolia/Xgeva with biosimilar –

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Novartis’ soon-to-be-divested Sandoz unit has constructive medical trial knowledge in hand for a biosimilar of Amgen’s blockbuster osteoporosis remedy Prolia (denosumab), clearing the best way for regulatory filings.

The section 1/3 ROSALIA examine confirmed that the copycat denosumab matched Amgen’s model on a number of pharmacokinetics, pharmacodynamics, efficacy, security, and immunogenicity measures in postmenopausal ladies with osteoporosis, mentioned Sandoz in a assertion.

Patents for denosumab expired in some European markets in June, though the drug remains to be protected in France, Italy, Spain, and the UK till 2025, when exclusivity additionally involves an finish within the US market.

Sandoz hasn’t given a timeline for a regulatory submitting for its denosumab biosimilar, however is anticipated to maneuver rapidly, given the potential market alternative.

First accepted in 2010, RANK ligand (RANKL) inhibitor Prolia stays an necessary drug for Amgen. The corporate recorded gross sales of $3.25 billion for the drug final 12 months, two thirds from the US market.

In the meantime, it booked one other $2 billion from Xgeva, a higher-dose denosumab-based product used to deal with tumours which have unfold to the bone, in addition to cancer-related hypercalcaemia.

“This necessary milestone signifies that we’re one step nearer to giving people dwelling with osteoporosis entry to a extra inexpensive, biosimilar model of this important medication, which can assist to vary the course of their illness,” commented Florian Bieber, world head of improvement for Sandoz Biopharmaceuticals.

Amgen firm is searching for to defend its osteoporosis franchise with UCB-partnered Evenity (romosozumab), an anti-sclerostin antibody that was accepted for postmenopausal osteoporosis in 2019 and introduced in $530 million final 12 months – an increase of greater than 50%.

The biotech is, nonetheless, dealing with one of many steepest patent cliffs within the biopharma business, with $4.35 billion TNF inhibitor Enbrel (etanercept) and $2.25 billion psoriasis remedy Otezla (apremilast) additionally within the ultimate years of patent safety. Taken alongside Prolia/Xgeva, the manufacturers account for effectively over 40% of Amgen’s present revenues.

Different firms engaged on biosimilar variations of denosumab embody Samsung Bioepis, Celltrion, and AryoGen Pharmed.

EU guidelines that each one biosimilars are interchangeable

The European Medicines Company (EMA) and the Heads of Medicines Businesses (HMA) have, in the meantime, printed a assertion confirming that each one EU-approved biosimilar medicines are interchangeable with their reference medication, or with an equal biosimilar, in a bid to deliver all member states into alignment.

Interchangeable standing signifies that a biosimilar is taken into account to haven’t any clinically significant distinction to the reference model in security, purity, or efficiency, so might be substituted for the reference drug with none prescriber intervention.

“Whereas interchangeable use of biosimilars is already practiced in lots of member states, this joint place harmonises the EU strategy,” they mentioned.

“It brings extra readability for healthcare professionals and thus helps extra sufferers to have entry to organic medicines throughout the EU.”

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