Who Are the Key Lucentis Biosimilar Players to Watch?

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 biosimilars

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 will expire in the US in June 2020 and 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:

1. Coherus-Bioeq

This one is a little complex—stick with it, as it could be the first to obtain FDA approval, as early as later this year.

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 for Coherus.

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 2020).

3. Biogen-Samsung Bioepis

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.

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.

A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG

On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this updated post, we highlight a German company, Formycon AG, which has eyes on the US marketplace.

Formycon acquired Scil Technology GmbH in 2012, and hired a new CEO the following year. Carsten Brockmeyer, PhD, has extensive experience in the biosimilar field, previously helping Hexal Biotech to develop EPO and filgrastim biosimilars for the European market.

Why you may be hearing more about this company: Formycon has two principal biosimilar targets, ranibizumab and ustekinumab. The company disclosed that “it successfully completed a Type IV pre-submission meeting with the US Food and Drug Administration (FDA) in December 2018 and clarified other pivotal issues. The filing with the FDA for the approval of FYB201 is expected at the beginning of the fourth quarter of this year.” A filing for the European Medicines Agency is planned for 2020. A phase 3 clinical trial of this agent was completed in June 2018. In the development of this agent, Formycon partnered with Bioeq GmbH, but it is unclear whether a marketing partner exists for a possible US launch.

The patent for ustekinumab (Stelara®) expires in 2023 (US) and 2024 (Europe). It is partnered with Aristo Pharma GmbH on the manufacture and testing of this interleukin 12/23 inhibitor (also known as FYB 202).

Formycon is in the early stages of developing a phase 3 trial for its biosimilar version of Eylea® (aflibercept or FYB 203), the next generation of macular degeneration treatment. It is partnered with Santo Holding GmbH on the development of aflibercept.

In other biosimilar news… Amgen decided to pull its EMA application for its infliximab biosimilar, likely due to market competition. The company has not taken similar action with regard to an FDA application for the same product, ABP 710. Considering that neither Samsung Bioepis or Pfizer failed to gain traction in the US marketplace for infliximab, Amgen must think that some biosimilar infliximab marketshare growth in the US is still possible.