Having seen its development partner Bioeq file with the FDA in December last year, Coherus is confident that it will be a leader in the US biosimilar ranibizumab market targeting Lucentis.
COHERUS IS CONFIDENT OF BEING IN THE VANGUARD OF BIOSIMILAR RIVALS TO ROCHE'S LUCENTIS OPHTHALMIC BLOCKBUSTER Source: Shutterstock
Coherus BioSciences believes the ranibizumab biosimilar candidate for which it has licensed US commercial rights from Bioeq puts it in pole position to lead the way on rivals to Roche’s Lucentis ophthalmic brand. The US pure-play biosimilars company expects to launch at market formation in mid-2021, after the Bioeq venture between Polpharma Biologics and the Strüngmanns’ Santo Holding filed with the US Food and Drug Administration in December last year.
Bioeq’s recent FDA submission fulfils the commitment that the partners made when striking the ranibizumab licensing deal in November last year that they would file the Lucentis biosimilar with the FDA by the end of 2019.
By gaining US rights to Bioeq’s FYB201 candidate through a deal that includes an equal profit split, Coherus said it would not only pull forward by around two years its prospective entry with biosimilar Lucentis, it would also save around $150m on developing its own CHS-3351 version of the treatment for wet age-related macular degeneration, edema and other eye conditions.
Speaking at the J.P. Morgan Healthcare Conference in San Francisco, Coherus’ president, chairman and CEO, Denny Lanfear, revealed that the US company had been looking for some time at ranibizumab candidates that it could license to complement its in-house development of a biosimilar to Regeneron’s Eylea (aflibercept) ophthalmic blockbuster.
“We looked at a lot of assets, and we were actually talking to Bioeq for 18 months before we concluded this,” he told conference delegates. Having been convinced by Bioeq’s analytical work showing an “excellent match” to Lucentis, he said Coherus had carefully reviewed its partner’s clinical data and regulatory dossier. “We have a high degree of confidence that this will be accepted by the FDA,” Lanfear stated.
Difficult Expression System Limits Competition
Given the difficulty of replicating the monoclonal antibody fragment via an escherichia coli expression system, Lanfear believed Coherus would be one of only a handful of potential players in the US biosimilar Lucentis market, along with Samsung Bioepis and marketing partner Biogen, which are currently taking their SB11 candidate through Phase III clinical trials. (Also see "Samsung Bioepis Adds To Biogen Collaboration" - Generics Bulletin, 7 Nov, 2019.)
“We don’t expect a whole lot of folks are going to show up in this particular market,” Lanfear told investors. Stressing the commercial and contracting similarities to the US oncology market in which Coherus’ Udenyca (pegfilgrastim-cbqv) has taken a 20% market share, he said Lucentis represented a $2bn market opportunity, with Eylea adding more than another $4bn.
However, to serve this $6.4bn US ophthalmics market, Lanfear believes Coherus will need only around 25 sales representatives. This, he explained, was because just 450 out of a total of 2,000 Lucentis accounts were responsible for 90% of sales by volume.
Coherus’ own CHS-2020 aflibercept candidate is currently in pre-clinical development, but the firm expects to take its Eylea rival into Phase III human trials next year, which a view to entering the US market in 2025. “I would say we are done in ophthalmology with Lucentis and Eylea,” Lanfear told conference delegates.
By contrast, in oncology Lanfear pointed out that Coherus lacked a biosimilar Herceptin (trastuzumab) candidate, while it might also consider licensing in non-biosimilar cancer treatments.
Licensed Bevacizumab From China’s Innovent
To round out its oncology pipeline, the Californian company recently licensed North American rights to a biosimilar version of Roche’s Avastin (bevacizumab) that its Chinese developer, Innovent Biologics, filed in its domestic market at the beginning of last year. The alliance also includes a non-exclusive option to sell Innovent’s biosimilar rival to Roche’s Rituxan (rituximab) in the US and Canada. (Also see "Coherus Acquires Bevacizumab Rights From Innovent" - Generics Bulletin, 14 Jan, 2020.)
Building on Innovent’s clinical trial in 450 patients with non-small cell lung cancer that Lanfear said had used the same study design and endpoints as research used by Amgen and Pfizer to get their biosimilar bevacizumabs past the FDA, Coherus intends to conduct a three-way bridging study comparing China-sourced Avastin, US-sourced Avastin and Innovent’s biosimilar candidate. Lanfear revealed that this would most likely take the form of a single-dose, parallel-design pharmacokinetics study in around 30 patients, conducted over a 99-day treatment period. In total, he added, Coherus anticipated spending around $10m-$15m before the project was ready to file in the US at the end of this year or early in 2021.
Acknowledging that the US market for biosimilar bevacizumab had already formed with the entry of Amgen’s Mvasi (bevacizumab-awwb) and Pfizer’s Zirabev (bevacizumab-bvzr) rivals to Avastin, Lanfear predicted that Coherus would be “fourth or fifth” to enter the US$3bn market. Forecasting discounts to the oncology brand of around 40%, he believed Coherus would be able to capitalize on the relationships and market understanding it had created through its pegfilgrastim launch to take around a tenth of the market as a late entrant.
For bevacizumab, and potentially for rituximab, Coherus intends to use its 70-member oncology salesforce and supporting commercial infrastructure.
Udenyca Pegfilgrastim Brand Passed 20% Share
This commercial set-up, Lanfear told investors, had enabled the company to end 2019 with a 20.5% share of the US pegfilgrastim market, meeting the forecast that the firm had made in August last year. (Also see "Coherus Set Sights On Taking Fifth Of US Pegfilgrastim Market" - Generics Bulletin, 6 Aug, 2019.)
Lanfear said its Udenyca biosimilar had fared well across the hospital and clinic sectors, and had also taken share from both Neulasta pre-filled syringes and the originator’s Onpro on-body applicator. Coherus is developing its own on-body device as a high priority.
Pointing out that Udenyca had entered the market six months after Mylan’s Fulphila (pegfilgrastim-jmdb), but without having to conduct a costly Phase III-type efficacy study due its reliance on an immunogenicity trial, Lanfear said its product had taken a fifth of the market “without dramatic price cuts during 2019.”
Describing how Udenyca had grown to track towards $500m in annual sales, he gave much of the credit to the extensive preparatory work the firm had done prior to launch, such as its sales team calling on 1,000 accounts and having built up a stockpile of 350,000 syringes so as to be able to provide supply guarantees. The biosimilar had been priced “just slightly below the average selling price of the originator” to deliver the best value to payers, he explained, while patients were well served by the firm’s Coherus Complete services portal and its co-pay assistance programs.
Expects Sandoz To Be ‘Well Behaved’
Acknowledging growing competition in the US pegfilgrastim market, Lanfear expected recent entrant Sandoz with its Ziextenzo (pegfilgrastim-bmez) brand to be “well behaved” on pricing and discounting, so as to maintain a sustainable market. (Also see "Sandoz Is Satisfied With US Pegfilgrastim Start" - Generics Bulletin, 28 Nov, 2019.)
Beyond transferring its commercial model from oncology into ophthalmology, Coherus believes its experience in US ‘buy-and-bill’ markets will also support its move into the inflammation sector in late-2023 when it is set to launch an alternative to AbbVie’s Humira (adalimumab) under the terms of a patent-litigation settlement.
Observing how regular price increases had raised the annual cost per patient for Humira to around $75,000, Lanfear forecasted that the anti-inflammatory agent would be a $17bn brand by the time it loses exclusivity in three years’ time.
By agreeing not to launch before 15 December 2023, Coherus looks likely to lag behind many of its peers that have agreed earlier entry dates in 2023. But Lanfear believes the firm – which intends to file for FDA approval of its CHS-1420 candidate around the end of this year, or early in 2021 – will be able to use its commercial nous to take a meaningful market share as a late entrant.
“We think that relationships between payers, PBMs and pharmaceutical companies are going to be blown apart and reshuffled,” he stated, predicting that payers would put adalimumab biosimilars on their formularies ahead of branded anti-inflammatory agents. “We think that a 10% market share target yields for us substantial revenues in the area of peak sales of $500m to $1bn.”