Supply Security And Competitive Pricing Will Support Byooviz Launch In US

Samsung Bioepis and Biogen’s US launch of Byooviz (ranibizumab-nuna) at the start of June represented several significant milestones. It was not only the first biosimilar rival to Genentech’s Lucentis to be launched worldwide, but also the first biosimilar available with approved ophthalmic indications, as well as the first US biosimilar launch for the two companies that have previously partnered on commercialization in Europe.

In the wake of the Byooviz launch – that has seen the pair compete with Lucentis aggressively on price, offering a biosimilar that is 40% cheaper than the brand (see sidebar) – Samsung Bioepis executive vice-president and development division leader Kyung-Ah Kim and Biogen senior vice-president and global head of biosimilars Ian Henshaw have spoken to Generics Bulletin about how the firms plan to capitalize on the groundbreaking opportunity, particularly when it comes to ensuring security of supply.

Asked about the significance of the launch for the two companies – both as the first ophthalmic biosimilar to be approved and launched in the US and as the first US product to be marketed under the collaboration between the two companies – Kim indicated that the pair would be building on the strength of their existing relationship.

Until very recently, this had included Biogen as a partner in the Samsung Bioepis joint venture with Samsung Biologics. (Also see "Biogen Exits Joint Venture As Samsung Biologics Buys Out Bioepis" - Generics Bulletin, 21 Apr, 2022.)

“Samsung Bioepis and Biogen have been maintaining a close and strong partnership for anti-TNF biosimilars in Europe for many years, and we are excited to launch our first product in the US market under our new partnership for ophthalmology products,” Kim emphasized.

“We understand that the US market dynamic is different from that of Europe or other countries,” Kim acknowledged, “and Samsung Bioepis and Biogen have been talking and reaching out to various stakeholders to understand their perception of biosimilars and prepare for a commercial launch in the US. We have been receiving feedback from those stakeholders, there is great anticipation around the entry of the first ophthalmic biosimilar in the US, and we are well prepared and excited to bring this product to market.”

Meanwhile, Henshaw said that while Byooviz represented “an extremely important launch for both companies,” it was “even more important for the people who will benefit from access to a more affordable and sustainable treatment option.”

With around 170 million people globally affected with neovascular (wet) age-related macular degeneration – and the prevalence of advanced AMD growing due to an aging population – Henshaw observed that “the growing prevalence of retinal vascular disorders worldwide indicates that there is growing demand for wider access to viable treatments.”

“We have seen in other therapeutic areas that the introduction of biosimilars leads to more people having access to treatment, often at an earlier stage of disease progression,” Henshaw pointed out. “That can make a tremendous difference to patients and caregivers.”

“When it comes to launch readiness, the most important factor is providing high-quality products to the market, based on market demands, without shortage or quality issues.”

Asked how Samsung Bioepis and Biogen had been laying the groundwork for the Byooviz launch, Kim said that a big part of the planning had been focused on ensuring uninterrupted supply and being able to respond to the needs of the market.

“I think when it comes to launch readiness, the most important factor is providing high-quality products to the market, based on market demands, without shortage or quality issues,” Kim suggested. “Not every company can do it very well, and our launch readiness is built on integrated efforts from pre-clinical/clinical trials, regulatory approvals, and manufacturing, to supply and distribution.”

Samsung Bioepis had been operating “a cross-functional task force to get ready for the launch,” Kim revealed, indicating that “the seamless work, from pre-clinical development to supply management, has allowed us to be ready for launch of Byooviz in the US.”

In particular, she noted, “while our products are manufactured in different locations around the world, we have strategically located some of the manufacturing sites for Byooviz in the US, which allows us to respond to market dynamics flexibly and in a relatively shorter period of time.”

Some Payers May Want To ‘Wait And See’

Commenting on how payers were expected to respond to the first ranibizumab biosimilar, Henshaw acknowledged that Biogen was prepared for a range of responses.

“Payers have had years of experience with biosimilars in immunology and oncology,” he pointed out, “and years of experience have shown that biosimilars bring benefits not only in terms of cost savings, but also in terms of accessibility, as they offer additional treatment options for patients.”

“As we begin to engage with payers about biosimilars for retinal patients in the US,” Henshaw outlined, “it is expected that payers will show interest and willingness to discuss biosimilars as one of the treatment options that will be considered along with other existing anti-VEGF agents.”

However, he acknowledged, “since Byooviz is the first biosimilar product to launch in the retinal market, we expect payers to show different reactions; for instance, some payers may want to wait and see until all biosimilars have entered the market and there is the established price for biosimilars, while some may want to quickly adopt biosimilars and start realizing cost savings by contracting with first-entry manufacturers.”

Ultimately, he commented, “we expect that payers will respond positively to the prospect of a ranibizumab biosimilar because it brings the potential to expand access to treatment affordably and sustainably.”

“Our focus is to ensure that all patients have reasonable access to lower priced treatments, and [we] continue to be encouraged by the early access Byooviz is receiving from national and regional payers.”

Market Size Suggests Significant Savings Potential

While Kim and Henshaw both declined to offer specific figures on the potential savings that could be realized through using Byooviz instead of Lucentis, both executives pointed to the size of the market as an indicator of the economic advantages and broader access that could be offered by the biosimilar.

“It is expected that the prevalence of AMD in the US would double to 22 million by 2050, and the prevalence of wet AMD, which accounts for approximately 10% of AMD cases, is also expected to increase in the coming years,” Kim said. “The economic burden of wet AMD treatment is substantial, including the costs related to anti-VEGF agents, and it is important to address the financial challenges, which may be exacerbated with the growing patient population.”

“While we cannot speculate on the healthcare savings,” Kim maintained, “Byooviz, a biosimilar with comparable efficacy and safety and offered at a more affordable price, has the potential to bring significant cost savings for payers, physicians, and patients.”

Meanwhile, Henshaw pointed to the significant discount offered by the biosimilar, as well as the amount that was currently spent on the Lucentis brand in the US.

“List price of biosimilars is usually 20%-40% lower compared to the reference product at the time of launch,” he observed, “and, for Byooviz we are launching at a wholesale acquisition cost that is approximately 40% lower than the current list price of Lucentis.”

“While we cannot speculate about specific savings, healthcare expenditures on Lucentis were more than $1.4bn in 2021 in the US.”

First-Mover Advantage Offers ‘Strong Foothold To Stay Competitive’

While specific commercial targets or expectations for Byooviz were not disclosed, Kim said that “considering that this is the first biosimilar product that will be launched in the US ranibizumab market, we have gained quite a strong foothold to stay competitive.”

In particular, she pointed to “our track record of providing high-quality products, along with supply readiness and setting an appropriate pricing strategy in collaboration with Biogen, as well as provider and payer engagement plans, and a patient support program.”

“Without speculating on market share or commercial targets,” Henshaw added, “it is important to note that this is an area of considerable unmet need for patients. We are confident that ophthalmologists, patients, and payers will respond positively to a more affordable, sustainable treatment option.”

Lucentis And Eylea Biosimilars Can Co-Exist

Asked about how Samsung Bioepis and Biogen’s collaboration on Byooviz meshes with the pair’s ongoing partnership to develop and launch their SB15 biosimilar rival to Regeneron’s Eylea (aflibercept) – another retinal disease treatment – both Kim and Henshaw were confident that the two products could co-exist happily in the ophthalmology sector.

“We are confident that ophthalmology healthcare providers, patients, payers, and professional societies will value having biosimilars referencing both treatments available,” Henshaw summarized, “just as the branded treatments of Eylea and Lucentis have co-existed in the sector.”

Expanding on this point, Kim underlined that “Lucentis and Eylea have been prescribed to patients for over 10 years, and each molecule has its own market segmented with different patient populations.”

“So, rather than competing against each other,” she continued, “we expect each molecule market to grow with multiple biosimilar players in competition, as patients will be prescribed with the most appropriate treatment according to their disease state, compliance to treatment, and financial status.”

And asked about the pair’s launch strategy and timing for Byooviz in Europe – where the biosimilar was approved last year (Also see "Samsung Bioepis Scoops First EU Lucentis Biosimilar As 2022 Date Looms" - Generics Bulletin, 24 Aug, 2021.) – as well as in Canada, where approval came early in 2022 (Also see "Canada Gives Samsung Bioepis A Further Ranibizumab Approval" - Generics Bulletin, 10 Mar, 2022.), Henshaw confirmed that “we are working together to determine the appropriate launch timing in Europe and other approved territories, but we cannot provide specifics at this point.”

“We are committed to global products and portfolios and continue to work with our partners and stakeholders to make Byooviz available,” he added, also noting that the firm would “engage in biosimilar education for healthcare professionals and patients to ensure that the ecosystem is ready for ranibizumab biosimilars at the appropriate time.”

“We are very excited to be working with ophthalmology healthcare providers to help them understand the science of biosimilars, and with payers and policymakers to ensure affordable and sustainable access to Byooviz.”

In the second part of this interview, Kim and Henshaw discuss in detail how education for healthcare professionals in ophthalmology will help build trust in biosimilars.  (Also see "Education And Data Will Be Key To Byooviz Uptake" - Generics Bulletin, 8 Jun, 2022.)