Developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, Byooviz (ranibizumab-nuna) is the first biosimilar referencing blockbuster Roche drug, Lucentis; it treats macular degeneration, macular edema, and myopic choroidal neovascularization.
The Roche drug was responsible for revenue of over CH 1.4bn (US$1.5bn) last year.
Byooviz demonstrated “comparative clinical efficacy and safety evaluations” to Lucentis, according to the FDA release on the US market registration yesterday [September 20].
And Byooviz, like Lucentis, is administered by intravitreal injection once a month.
The US backing for Byooviz follows regulatory approvals for the therapy in the EU and the UK last month.
Samsung Bioepis and Biogen entered into a commercialization agreement for two ophthalmology biosimilar candidates in November 2019. In line with a global license agreement entered into with Genentech, Samsung Bioepis and Biogen can only market Byooviz in the US from June 2022.
Byooviz is Samsung Bioepis’ fifth biosimilar approved in the US, following the approval of Renflexis (infliximab-abda) in April 2017, Ontruzant (trastuzumab-dttb) in January 2019, Eticovo (etanercept-ykro) in April 2019, and Hadlima (adalimumab-bwwd) in July 2019.
Commenting on yesterday’s approval, Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said: “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”
The action is the latest in a string of events on Capitol Hill and in the Biden Administration in support of biosimilars, noted the Biosimilars Forum.
“Several months ago, President Biden issued an executive order directing the Department of Health and Human Services to take steps to promote biosimilar competition, and bipartisan legislation in the House and Senate continues to build momentum.”
To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar, for the treatment of a variety of health conditions. The EU has 50 biosimilar approvals, while the APAC region has authorized the use of 173 biosimilars.
Quentin Horgan, senior drugs database analyst at GlobalData, presenting at CPhI North America in August, said biosimilar approvals come in waves of approvals in different regions, which peak and then subsequently drop.
The US is in the midst of its own biosimilar wave.
“It now looks to be peaking and will most likely begin to experience its own decrease, similarly to Europe, in the near future, due to a lack of pipeline products able to take advantage of future losses of expiry,” he told BioPharma-Reporter.
The EU experienced a biosimilar wave ahead of regions such as the US and Asia-Pacific because it created the first biosimilar-specific approval pathway in 2005, and subsequently approved the first biosimilar somatropin in 2006. In addition, the region has had a strong uptake of biosimilars over brand biologics and, therefore, has one of the biggest biosimilar markets, he said.
That EU biosimilar approval wave would appear to have peaked in 2018 and is now experiencing a decline, which is expected to continue.
In contrast, the APAC region appears to be beginning its own biosimilar wave with the number of such products on the rise in those markets, particularly in China, noted Horgan.
That increase, he said, can be linked to regulatory changes brought in by the Chinese National Medical Products Administration (NMPA) such as it releasing the first official guidelines for an established biosimilar pathway in 2015 coupled with it lowering the costs for companies and reducing barriers to performing biosimilar R&D; all those efforts were aimed at helping stimulate biosimilar market growth in the Asian behemoth, explained Horgan.
When asked whether recent US legislative moves and education programs for health care providers, payors, and patients would likely create further understanding and access to biosimilars in the US, Horgan said:
“The US market has already attempted to educate payors and patients more, in previous years, with the FDA implementing the Biosimilar Action Plan (BAP), to support education on biosimilar drugs, building on the FDA’s previous Biosimilar Education and Outreach Campaign.
"Reports such as the ‘Considerations in Demonstrating Interchangeability with a Reference Product’ have helped give clarity to manufacturers and simple documents like ‘What is a Biosimilar?’ give clear and concise information for both patients and payers.
“However, the impact on biosimilar uptake appears to be negligible, and many believe that interchangeability status, allowing for automatic substitution, would drive use far more.”
In July 2021, the FDA approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a diabetes treatment. Semglee is both biosimilar to and interchangeable with Lantus (insulin glargine).
And the US regulator said back then that it expects to approve more interchangeable biosimilar products in the future.