Europe gets its First Biosimilar Competitor after European Commission Approves Samsung Bioepis’ Drug “Byooviz”

After the European Commission authorized Samsung Bioepis’ copycat drug Byooviz, Novartis, and Roche’s popular eye treatment Lucentis now has its first biosimilar competitor in Europe.

Biogen will sell Byooviz (ranibizumab, also known as SB11) in the EU for the same indications as Lucentis, including wet age-related macular degeneration (AMD) and diabetic macular oedema (DMO).

Lucentis’ key patents aren’t set to expire in Europe until next year, but Samsung Bioepis and Biogen are already planning to launch the drug as soon as the patents expire.

Although the drug’s patent protection in the United States expired last year, Samsung Bioepis and Biogen are still waiting for FDA approval, which is expected in November.

Lucentis was first licensed in Europe in 2007 for wet AMD and has since grown in popularity thanks to a slew of new indications. The drug’s sales peaked in 2019, when Roche made $1.8 billion and Novartis made $2.1 billion from it.

Last year, lockdown limitations prompted by the coronavirus pandemic cut Roche’s sales to $1.4 billion and Novartis’ to $1.9 billion, but sales rebounded in the first half of this year to about pre-COVID-19 levels.

Biosimilars are near-copies of complex biologic medications generated in cells that have been studied and evaluated in clinical trials and found to have the same safety and efficacy profile as the original treatment.

Other potential Lucentis biosimilars might emerge from Hospira/Pfizer, Bausch + Lomb, or Coherus/Bioeq, who all have biosimilars reaching the end of clinical trials.

Byooviz’s availability could have an influence on Bayer and Regeneron’s Eylea (aflibercept), which has a few years of patent protection left but could be harmed by low-cost competitors.

Novartis has attempted to defend its Lucentis business by developing Beovu (brolucizumab), a follow-up to Lucentis that enables longer dosing intervals – an appealing prospect for patients because injections must be put into the eye – but has been hampered by some safety concerns.

In the meantime, Roche is awaiting an FDA decision on an implant version of ranibizumab that can extend treatment intervals to six months or longer and has created a bispecific antibody called faricimab that requires less frequent dosage.

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