Biosimilar Competition for Ranibizumab Lies Ahead as Developers Undertake Phase 3 Trials

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

Ranibizumab, which is approved to treat neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME, may not be among Roche’s biggest-selling innovator biologics. However, with $1.8 billion in sales in 2016, ranibizumab has several biosimilar developers eager to capture a share of the retina drug’s market.

Among those developers is Samsung Bioepis, which will begin a phase 3 trial for its SB11, a proposed ranibizumab biosimilar, next month. The randomized, double-masked, parallel group, multicenter study will compare the safety, efficacy, pharmacokinetics, and immunogenicity between SB11 and the reference ranibizumab in patients who have neovascular AMD. The subjects will be randomized in a 1:1 ratio to receive either a 0.5-mg intravitreal dose of SB11 or the branded Lucentis every 4 weeks. The primary outcomes measured will be the change from baseline in best corrected visual acuity at week 8 and change from baseline in central subfield thickness at week 4. Samsung Bioepis projects that it will have collected its primary outcome data by April of 2019.

Also in phase 3 development with a ranibizumab biosimilar is Formycon. The German company is currently undertaking a phase 3 trial of its FYB201 in patients with neovascular AMD. The company reports that it developed its study in consultation with both the European Medicines Agency and FDA in hopes that it will achieve regulatory approval in both markets. Formycon, which expects to have collected its primary outcome data by March of 2020, says that it hopes to launch its biosimilar immediately upon patent expiry of the reference product in Europe (2022) and in the United States (2020).

Pfenex, after having reassumed the rights to PF582 from Pfizer in 2016, is also developing a biosimilar. Indian drug maker Intas launched a “similar biologic” (Razumab) in 2015, but manufacturing issues with the drug caused ocular inflammation in approximately 10% of patients receiving the drug, leading the manufacturer to revise its production process.

Roche, meanwhile, is attempting to maintain its hold on the ranibizumab market after its product loses patent protection. The company is currently collaborating with Ascendis Pharma on a longer-acting ranibizumab that could reduce the frequency of intravitreal injections to as little as 2 times per year.