Formycon AG and Bioeq AG have received FDA approval for Nufymco (ranibizumab-leyk), an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab injection).
Let’s first take a look at Formycon.
The German biopharmaceutical developer of biosimilars specializes in three key therapeutic areas (among others), with ophthalmology a key focus.
Speaking of ophthalmology: The company is no stranger to biosimilar approvals, as it has previously received clearance for:
- FYB201/CIMERLI (ranibizumab-eqrn)
- Biosimilar to Genentech’s Lucentis (ranibizumab)
- Developed in partnership with Bioeq
- Notably: The first Lucentis biosimilar approved for all five indications
- FYB203/AHZANTIVE (aflibercept-mrbb)
- Biosimilar to Regeneron, Inc’s EYLEA (aflibercept 2 mg injection)
- Developed in partnership with Kling Biopharma GmbH
And what do we know about Bioeq?
This is a Swiss biopharmaceutical joint venture between Formycon and Polpharma Biologics Group (a Swiss biopharma company) that develops, licenses, and markets biosimilars.
And on the subject of biosimilars, these differ from generics, right?
That’s correct. Here are a few key distinctions between these two types of off-brand drugs:
- Generics are designed as exact chemical copies of their reference biologics (name-brand drug counterpart).
- Biosimilars, on the other hand, are highly similar (but not identical) versions of their reference biologics, with minor differences allowed—providing they don’t result in clinically meaningful differences in the resulting safety and efficacy.
Duly noted. Now to this latest biosimilar—what do we know?
Nufymco (ranibizumab-leyk) is an interchangeable biosimilar to Lucentis, a vascular endothelial growth factor (VEGF) inhibitor that initially received U.S. regulatory clearance in 2006.
To note: Nufymyco is the second ranibizumab biosimilar to receive FDA approval (see above for details on that first biosimilar, which was cleared in 2022).
What are its indications?
The biosimilar is approved for the same five indications as Lucentis:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME
- Diabetic retinopathy (DR)
- Macular edema due to retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
And the dosing requirements?
We’ll refer to Lucentis’s prescribing information (PI) for this, which advises that the therapeutic—packaged in a single-dose prefilled syringe—be administered as an intravitreal (IVT) injection.
Here’s a look at each indication’s dosage:
- Wet AMD: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- To note: Though not as effective, patients may also be treated with:
- 3 monthly doses followed by less frequent dosing with regular assessment
- 1 dose every 3 months after 4 monthly doses with regular assessment
- To note: Though not as effective, patients may also be treated with:
- Frequency: Once a month (approximately 28 days)
- Macular edema due to RVO: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- DME and DR: 0.3 mg (0.05 mL of 6 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- mCNV: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Initially administered once a month (approximately 28 days) for up to 3 months
- To note: Patients may be re-treated if needed
- Frequency: Initially administered once a month (approximately 28 days) for up to 3 months
Any contraindications to be aware of?
Per the name-brand PI (see Section 4.1), the IVT injection is contraindicated in patients with:
- Ocular or periocular infections
- Hypersensitivity to ranibizumab or any of the excipients in the drug
- Reactions may develop as severe intraocular inflammation (IOI)
How about warnings or precautions?
Definitely a few to keep in mind as potential adverse reactions (per Section 5 of the PI):
- Endophthalmitis and retinal detachments
- Intraocular pressure (IOP) increases
- Arterial thromboembolic events
- Potential fatal events (though risk is low, a possible relationship tied to IVT use of VEGF inhibitors can’t be ruled out)
- Retinal vasculitis with or without occlusion (typically in the presence of preexisting IOI or post-treatment with other IVT agents)
Any other adverse reactions?
Serious adverse reactions related to the injection procedure were noted as occurring in <0.1% of IVT injections evaluated in clinical trials used to support the name-brand drug’s approval (see Section 6 of the PI).
- Examples of these include: endophthalmitis (as listed earlier), rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
… is that it?
Not quite. A complete look at reported ocular reactions among ranibizumab-treated patients (versus placebo) in clinical trials can be found in Section 6 of the PI.
- The most common: conjunctival hemorrhage, eye pain, and vitreous floaters.
Noted. Now, what do we know about commercialization plans for Nufymco?
In announcing its regulatory approval, Formycon also shared that it has partnered with Zydus Lifesciences Limited to market the Lucentis biosimilar in the United States.
Take note: This life sciences company already has a global footprint spanning the U.S., India, and other international markets—and previously obtained the exclusive North American rights to another of Formycon’s biosimilars.
Nice So … where (and when) will the biosimilar be available for purchase?
No word yet on that front … but check back at the Formycon website for updates on this in the very near future.