Note: This is an update to a January 2020 post to include Lupin’s investigational agent in phase 3 trials.
Roche’s reference product Lucentis® (ranibizumab) seems to be the next likely target for biosimilar competition. Sales of the drug in the US were last reported to be $1.5 billion in 2017, but Roche’s revenues from Lucentis are expected to slip, owing to competition from Eylea® (aflibercept) primarily and some newer agents. And new Lucentis biosimilars will hasten that decline.
Ranibizumab is approved for use for several ophthalmologic
indications, including wet age-related macular degeneration, diabetic
retinopathy and diabetic macular edema, myopic choroidal neovascularization,
and macular edema following retinal vein occlusion.
According to reporting by the UK-based Generics and Biosimilar Initiative (GaBI), the patents on Lucentis expired in the US in June 2020 and will expire in Europe in 2022. GaBI had found some 10 organizations or partnerships working on investigational ranibizumab biosimilars, but little updated information (some were reported as early as 2015).
Today, our research into the Lucentis biosimilar space revealed just a couple of active players, but with rapidly advancing plans. Here are the three initiatives reported publicly:
This one is a little complex—stick
with it, as it could be the first to obtain FDA approval, as early as later
Formycon AG, a German
manufacturer, gave Bioeq IP AG exclusive global commercialization rights to
FYB201, Formycon’s ranibizumab biosimilar. In November 2019, with Formycon’s
assent, Bioeq signed an agreement
with Coherus Biosciences to commercialize the biosimilar in the US.
At the recent
JP Morgan investor conference, Coherus President Denny Lanfear disclosed
that Bioeq filed for FDA approval in December 2019. Coherus is expecting FDA
acceptance of the application shortly, and a fourth quarter 2020 decision. This
could set up a product launch, according to Coherus, in 2021.
Interestingly, Coherus originally had a different biosimilar ranibizumab in its
own pipeline. This agent, CHS-3351, fell by the wayside a couple of
years ago. The deal with Bioeq seems to have created a new ranibizumab opportunity
2. Xbrane-Stada Arzneimittel
Sweden-based Xbrane signed an agreement with the German
generics manufacturer Stada Arzneimittel to co-develop Xbrane’s Lucentis
biosimilar. This agent, currently dubbed Xlucane™, is being tested in a phase
3 trial involving 580 patients with age-related macular degeneration, which
is slated for completion in February 2021 (interim results available in May
Samsung Bioepis completed its phase 3 trial of SB11 in December 2019 (primary completion date of May 2019). This trial comprised 705 patients with neovascular age-related macular degeneration. SB11 seems poised to be submitted for approval via the 351(k) biosimilar pathway, and Samsung’s deal with Biogen (already a part owner of the joint venture with Samsung Biologics) for commercialization. Therefore, Biogen will take the marketing reins once an FDA decision has been given. If Samsung submits its filing in Q2 2020, a launch could be possible in Q2 2021, assuming a positive decision.
In September 2020, the India-based manufacturer Lupin began a phase 3 trial of its investigational ranibizumab biosimilar LUBT010. This trial will include 600 participants in total, who will receive either LUBT010 or Lucentis for 12 months. The study is scheduled for completion in October 2022. However, it is not confirmed that Lupin will seek to market this agent in the US. The study population is unclear, as only one eye clinic located in India is listed as recruiting patients, in an ClinicalTrials.gov update posted December 30, 2020. Assuming the patient population represents multiple countries, it may be possible for Lupin to submit an FDA application as early as Q1 2023, with a potential launch of Q1 2024.
Are There Any Other Active Players Out There?
The development of PF582 by Pfenex has been on hold since
2018, after the company was handed back the full rights to the agent by
former partner Hospira. Pfenex no longer lists this product (or any other
biosimilar for that matter) on its pipeline. The drug had progressed through
phase 1/2 studies, but has not advanced.
None of the other significant players in the biosimilar
industry (including Pfizer, Sandoz, Mylan, Amgen, Celltrion, or Biocon) have
publicly announced a ranibizumab biosimilar program at present.