Will Ranibizumab Biosimilars Piggyback on the Success of Roche’s Blockbuster Lucentis?

28th August 2017 (Last Updated August 28th, 2017 18:30)

The cost of biologic therapies, such as the anti-vascular endothelial growth factor (anti-VEGF) drugs, can be prohibitively high. In today’s cost-conscious environment, global healthcare systems need to seek out cheaper alternatives.

The cost of biologic therapies, such as the anti-vascular endothelial growth factor (anti-VEGF) drugs, can be prohibitively high. In today’s cost-conscious environment, global healthcare systems need to seek out cheaper alternatives.

The wet age-related macular degeneration (wAMD) market is dominated by anti-VEGF therapies such as Lucentis, Avastin, and Eylea.

The US patent covering Roche’s Lucentis will expire in 2020. Bioeq, a key subsidiary of Santo Holding, is developing biosimilar copy of Lucentis called FYB-201 in partnership with Formycon, with the aim of being the first to bring a biosimilar to market following the US patent expiry of Lucentis. FYB-201 is in Phase III of development for wAMD, and is being directly compared with Lucentis for its efficacy and safety in wAMD patients.

Formycon received advice from the European Medicines Agency (EMA) and a scientific advice letter from the US Food and Drug Administration (FDA) in 2014 and 2015, respectively, regarding the preclinical and clinical development of FYB201. It also obtained a German good manufacturing practice (GMP) certificate in 2015, which confirms that Formycon conducts analytical testing in compliance with EU GMP regulations.

The majority of key opinion leaders (KOL) interviewed by GlobalData expressed their interest in using a cheaper version of the pricy branded anti-VEGFs, as long as their safety and efficacy are equivalent to Lucentis.

However, by the time the first biosimilar of Lucentis comes to market, novel long-acting anti-VEGF drug RTH258 will be available for wAMD patients, which has the potential to fill one of the greatest unmet needs in this space: the treatment burden of the frequent intravitreal (IVT) injections associated with the currently available anti-VEGF therapies.

The novel anti-VEGFs, designed to have longer duration of 12 weeks, as opposed to Lucentis’ and Eylea’s monthly and bimonthly injections, respectively, will have to prove their duration in a 'real-world' setting.

In clinical practice, Lucentis and Eylea are dosed at similar frequencies despite a monthly or bimonthly use by label, due to physicians’ adoption of 'as needed' (PRN) or 'treat-and-extend' (TAE) dosing regimens to reduce treatment burden in those patients who respond well to less frequent injections. Despite the bimonthly administration of Eylea demonstrating gains in visual acuity statistically comparable to monthly Lucentis injections, in practice, some patients require more frequent Eylea injections.

Eylea was well received in the wAMD and other ophthalmic disease areas, and in the past few years, its revenue exceeded Lucentis’, possibly due to both physician preference and marketing strategies.

Already announced data shows that around 50% of wAMD patients will benefit from the thrice-monthly RTH258 regimen without additional unscheduled treatment, while the other 50% may require more frequent administration.

Based on primary research carried out by GlobalData, RTH258 will be used as a second-line of therapy by many physicians primarily in those patients who require more frequent administration of the already established, highly effective anti-VEGFs. Provided it proves successful in the real-world setting, the use of RTH258 will become more popular and likely replicate Eylea’s victory.

GlobalData expects that the launch of the new improved products will reduce the market potential of FYB201, but the drug will still have a window of opportunity to gather a share of this lucrative market before longer-acting anti-VEGFs are adopted in the first line. Furthermore, once authorised, the use of a Lucentis biosimilar will also depend on the contracts that the companies will manage to land with providers, similarly to how these contracts currently influence the choice between Lucentis, Avastin, and Eylea in many regions.