Eye on Pharma: 2 US Launches, an EMA Filing, and Denosumab Results

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Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Amneal Pharmaceuticals filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.

Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Biogen filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.

US Launches

This week, Coherus Biosciences launched Cimerli (ranibizumab-eqrn), the first ophthalmology biosimilar to receive an interchangeable designation, on the US market. The company announced in mid-September that the product would launch on October 3.

Cimerli references Lucentis (ranibizumab) and was the second ophthalmology biosimilar to be approved in the United States. Cimerli’s list prices is being set at a 30% discount to Lucentis, amounting to $1360 for the 0.5 mg dose and $816 for the 0.3 mg dose.

Ranibizumab products are used to treat a number of retinal conditions, including neovascular (wet) age-related macular degeneration, diabetic edema, diabetic retinopathy, and myopic choroidal neovascularization.

“Coherus has both the opportunity and the capability to be very successful with the Cimerli launch, as we start the next leg of our revenue inflection towards our target range of $1.2B to $2.2B in 2026,” said Denny Lanfear, CEO of Coherus, in the statement.

Additionally, Amneal Pharmaceuticals launched Alymsys (bevacizumab-maly) for the treatment of several types of cancer. Alymsys was approved in April 2022 and was the third biosimilar referencing Avastin (bevacizumab) to receive a thumbs up from the FDA.

EMA Filing for Tocilizumab Biosimilar

Biogen announced that its a marketing authorization application (MAA) for its tocilizumab biosimilar candidate (BIIB800) has been accepted by the European Medicines Agency (EMA) for review. The biosimilar references RoACTEMRA.

The reference product is used in the treatment of rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and severe COVID-19 in adults receiving corticosteroids and require supplemental oxygen or mechanical ventilation.

The MAA includes results from a multicenter, multinational, randomized, double-blind, parallel-group, active-control phase 3 trial that demonstrated comparable safety, efficacy, immunogenicity, pharmacokinetic, and pharmacodynamic profiles between the biosimilar and RoACTEMRA.

Biogen and Bio-Thera Solutions entered into a commercialization agreement for BIIB800 in April 2021, through which Biogen will have exclusive regulatory, manufacturing, and commercialization rights to the biosimilar in all countries except China, including Hong Kong, Macau, and Taiwan.

“If approved, BIIB800 will be a valuable treatment option for people with chronic immune mediated inflammatory diseases. We believe our biosimilar offerings are essential as we collaborate with payers and health authorities with the goal of generating savings to ensure sustainable healthcare systems,” said Ian Henshaw, head of global biosimilars at Biogen in a statement.

Positive Results for Sandoz’ Denosumab

Sandoz released positive data from the ROSALIA phase 1/3 clinical study assessing the biosimilarity of its denosumab biosimilar candidate and the reference product (Prolia).

Denosumab products are used to treat osteoporosis in postmenopausal women, protect men who are at a high risk of fracture, address therapy-induced bone loss, prevent skeletal-related complications in cancer that has spread to the bone, and treat giant cell tumor of the bone.

The trial included 527 postmenopausal women with osteoporosis who were randomized to receive the biosimilar or the reference product for up to 78 weeks. The results confirmed that the safety and efficacy of BIIB800 was comparable with Prolia.

“Biosimilars have the opportunity to create a substantial positive impact on patient access and healthcare systems sustainability…. Therefore, this important milestone means that we are one step closer to giving individuals living with osteoporosis access to a more affordable, biosimilar version of this critical medicine, which may help to change the course of their disease,” said Florian Bieber, global head of development at Sandoz Biopharmaceuticals.

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