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: Archigen Biotech

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. 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 post, we highlight a joint venture between AstraZeneca and Samsung BioLogics, Archigen Biotech Ltd.

Archigen BiotechEstablished in 2014, Archigen has focused on the development of a single biosimilar drug, SAIT101, which will compete in the rituximab space against the likes of Rituxan® and MabThera® (and perhaps other approved rituximab biosimilars). According to a 2016 report, Samsung Electronics had initially sought to develop this agent in 2012, but abandoned the effort soon afterward because of lack of capital.

One of the partners, Samsung BioLogics, also has a stake in Samsung Bioepis (with Biogen). Archigen says on its website that it will be relying on “leading global Contract Research Organizations and Contract Manufacturing Organizations to ensure efficient execution of drug development activities.”

Why you may be hearing more about this company: Its phase 1 study of SAIT101 was implemented October 2016, and clinical results should be available soon. This study was conducted with 246 patients with rheumatoid arthritis, testing the drug against both reference drugs, and included a switching arm. This is unusual for both the size and extent of a phase 1 investigation. Additionally, the organization did not conduct a separate drug trial in healthy volunteers, which is often a first step in analyzing the medication’s pharmacokinetics and pharmacodynamics. Instead, Archigen is moving directly to a phase 3 trial in patients with follicular lymphoma. This study started in January 2017, with initial results expected in May 2019. The phase 3 trial will have over 300 patients, and use MabThera as the comparator.

Based on these dates, a 351(k) filing could be achieved as early as the fourth quarter of 2019, with potential approval in the third quarter of 2020.

Archigen Biotech has not posted on its website any information about subsequent drug targets. Indeed, its website is sparse. It is possible that following the clinical development of SAIT101, Archigen will be more focused on new branded agents, leaving Samsung Bioepis to work on its biosimilar portfolio.