Christine Blank

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The FDAapproval of the first biosimilar to Roche’s blockbuster drug Lucentis for neovascular (wet) age-related macular degeneration (AMD) and other eye diseases is definitely significant, according to George A. Williams, M.D., a clinical spokesperson for the American Academy of Ophthalmology.

The biosimilar, Byooviz (ranibizumab-nuna), was approved by the FDA last month as a treatment of AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz’s approval is “significant” because it is the first FDA-approved biosimilar for an ophthalmic indication, and “it’s a biosimilar for one of the most popular and effective therapies we have in the ophthalmic space,” noted Williams in a recent interview 

 Williams, a retina specialist and former president of the American Academy of Ophthalmology, is chair of the department of ophthalmology and director of the Beaumont Eye Institute at Beaumont Health in Royal Oak, Michigan.

Byooviz is the first ophthalmology biosimilar approved in the U.S, but it won’t be available in the U.S. till June 2022 because of a global licensing agreement with Genentech, which is part of Roche. The Lucentis biosimilar was developed by Samsung Bioepis, a Korean company but will be marketed by Biogen in the U.S. as Byooviz.

The approval and marketing Byooviz is expected to cut into the U.S. sales of Lucentis, which came to 

Before Lucentis was approved in 2006, 90% of people who developed wet AMD would be legally blind within one year, Williams noted. "This therapy completely reversed that. Now, less than 10% of people with wet AMD will end up legally blind if starting appropriate treatments.”

“The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US,” said Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis, in a press release issued jointly by the Korean company and Biogen

About 11 million Americans live with AMD and the prevalence of advanced AMD is increasing because of the aging U.S. population, noted the Samsung Bioepis and Biogen.

“Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems,” Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, said in a press release when the approval was announced.

However, pricing of the new biosimilar is unclear. The exact cost savings will be an important factor in whether the biosimilar gains acceptance and becomes commonly prescribed, Williams said.

“As physicians, the American Academy of Ophthalmology has always believed that more treatments options that benefit patients out there is a good thing. We’re fortunate to have three FDA-approved and one off-label anti-VEGF available and it will take some time to sort out how this biosimilar will benefit patients,” Williams added.

European and British drug regulators approved Byooviz in August.

The FDA has approved four other biosimilars developed by Samsung Bioepis: Renflexis (infliximab-abda), Ontruzant (trastuzumab-dttb), Eticovo (etanercept-ykro) and Hadlima (adalimumab-bwwd).

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Exactly how Byooviz will be priced  is unclear, noted George W. Williams, M.D., a retina specialist and past president of the American Academy of Ophthalmology. The exact cost savings will help determine whether the biosimilar gains acceptance.

AAO Spokesperson: FDA Approval of Byooviz, First Biosimilar to Lucentis, Is “Significant"

The use of personalized medicine is vital for improving outcomes in patients with nonalcoholic fatty liver disease (NAFLD) in the future, say researchers.

“The current therapeutic landscape of NAFLD is rapidly evolving with an increasing number of molecules that treat key factors involved in its progression, but that still have a limited or no ability to effectively reverse fibrosis,” wrote Manuel Romero-Gomez of the University of Seville and his co-authors in the journal 

. “Management of this disease will probably require a combination of sequential and personalized treatments as a result of its complex and dynamic pathophysiology.”

The national multicenter study in Spain led by CIBER for Liver and Digestive Diseases (CIBEREHD) involved five years of monitoring patients with metabolic liver disease.

The prevalence of NAFLD has increased to 25% in the general population and could double by 2030, the researchers noted. Liver fibrosis is the main indicator of morbidity and mortality, and recent estimations suggest a substantial number of individuals with undiagnosed advanced liver disease.

“Strategies to monitor advanced fibrosis are essential for early detection, referral, diagnosis and treatment in primary care and endocrine units, where NAFLD and consequently liver fibrosis are more prevalent,” wrote Romero-Gomez and his colleagues.

Blood-based noninvasive methods such as liquid biopsy could be used to stratify patients according to the risk of the progression of fibrosis, they said, and could be combined with imaging techniques to improve stratification.

Powerful new diagnostic tools such as magnetic resonance electrography (MRE), a technology that combines MRI imaging with low-frequency vibrations to create a visual map, are emerging and might prevent the need for liver biopsy in the near future, the authors wrote.

Personalized medicine allows for clinicians to “establish a cause or predict risk of illness and design a personalized plan to prevent or detect diseases early,” said 

, M.D., chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai, in an article posted on 

“It allows for the use of medications and other treatments based on what would work best for each individual and also avoid adverse effects,” Friedman was quoted as saying,

One example of personalized medicine in liver disease care is utilizing whole exome sequencing, according to Friedman, who shared the example of a Yale University study in which the testing was used in 19 adults with idiopathic liver disease.

Five out of the 19 patients had identifiable monogenic disorders affecting five genes. The presenting features were typically lean nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis, Friedman said.

“Personalized medicine will slowly but surely integrate into clinical hepatology, but this will be evolutionary, not revolutionary,” Friedman said. “Barriers to implementation will wane as we develop better systems to integrate this information into the medical record, so doctors don’t have to become geneticists.”

Liquid biopsies and new MRI technology may help clinicians monitor and stratify patients by the likelihood of whether their liver disease will worsen.

Personalized Medicine Vital to Future of Liver Disease Care

FDA approved the first biosimilar to Roche’s blockbuster drug Lucentis for neovascular (wet) age-related macular degeneration (AMD) and other eye diseases today. The federal regulatory agency cleared Byooviz (ranibizumab-nuna), to treat AMD, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

The approval and marketing Byooviz is expected to have a make a major dent in the U.S. sales of Lucentis, which came to 

“Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen.

The drug won't be available till next year but is expected to dent sales of 
Roche's blockbuster for age-related macular degeneration and other eye diseases.

FDA Clears First Biosimilar to Lucentis

A large Netherlands study demonstrated that rituximab biosimilars (R-biosimilars) produced a 43 percent reduction in annual costs. In addition, three-year overall survival did not differ between diffuse large B-cell lymphoma (DLBCL) and those receiving rituximab, according to the researchers.

Researchers at the Netherlands Comprehensive Cancer Organisation (IKNL) in Utrecht, The Netherlands, and other facilities, wrote in the journal 

 that the Dutch Association of Medical Specialists stated to adopt Biosimilars into standard of care in 2017.

As a result, due to the “considerably lower purchase costs of R-biosimilars compared with R-originator (up to 50%), the Netherlands was one of the first countries to implement R-biosimilars in its health care system,” the researchers wrote.

In fact, by the end of 2018, 91% of rituximab (manufactured by Genentech and marketed in the US as Rituxan by Biogen) purchased in the Netherlands were biosimilars.

“R-biosimilars may have major health economic consequences. With a worldwide R-originator sales increase of 1% in 2017, purchase percentages of R-originator decreased by 8% and 4% in 2018 and 2019, respectively,” the researchers wrote.

The highest conversion rate occurred in Europe with a 33% purchase reduction of the R-originator in 2019. “Despite approval in 2018, the first R-biosimilar was only marketed in November 2019 in the United States, In that same year, the relative expenditure on R-originator in the Netherlands was 43% lower than in 2015,” they noted.

Despite the known cost savings, the authors wanted to test the real-world overall survival rates of patients with newly diagnosed DLBCL taking R-biosimilars to see if they were equivalent to that of rituximab.

They evaluated more than 4,400 patients in a nationwide, population-based cancer registry in the Netherlands. The patients, diagnosed between 2014 and 2018, received at least 1 cycle of rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP).

“Collectively, our data show that patients with DLBCL benefit equally from R-originator or R-biosimilars combined with CHOP treatment,” the researchers wrote.

Other studies have also supported the use of Rituxan biosimilars to treat DLBCL. In a 2020 study, published in 

, researchers found that the rituximab biosimilar CT-P10 (Truxima, Celltrion) successfully replaced rituximab in diffuse large B-cell lymphoma (DLBCL) treatment.

“These data support the ability of CT-P10 to successfully replace originator rituximab in DLBCL treatment and, given the lowered financial barrier, to improve the overall prognosis for DLBCL patients,” the researchers wrote.