News Briefs


Biogen, Samsung Bioepis launch Lucentis biosimilar

vial generic injectable teaser

Biogen and Samsung Bioepis are launching Byooviz (ranibizumab-nuna), a biosimilar of Genentech’s Lucentis (ranibizumab).

The Food and Drug Administration approved Byooviz, a vascular endothelial growth factor inhibitor, in September 2021 for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. It is the first FDA-approved ophthalmology biosimilar, the companies said.

The list price will be $1,130 per single-use vial to administer 0.5 mg via intravitreal injection, which is 40% lower than the current list price of Lucentis, the company said.

“The launch of Byooviz in the U.S. marks an important moment for patients, healthcare providers, payers and the entire healthcare system,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen. “Patients suffering from retinal vascular disorders now have a more affordable treatment option.”

Healthcare provider engagement, promotional activity and collaborations with professional societies and patient advocacy groups have commenced.

Byooviz will be commercially available on July 1, 2022, through major distributors across the United States.

“Our research with physicians shows cost is cited as a leading barrier to patients initiating treatment, with one-third of patients unable to afford medication,” Henshaw said.“ Byooviz has the potential to expand access to patients suffering from retinal disorders that can result in permanent vision loss while also saving the U.S. healthcare system billions of dollars.”

Neovascular (wet) AMD, although less common than dry AMD, is responsible for the majority of the severe vision loss or blindness associated with AMD. Anti-VEGF therapies have become a standard of care treatment for wet AMD, but in real-world settings, costs related with wet AMD treatment often raise challenges in achieving optimal clinical outcomes. The companies said that biosimilars, which are biologics with similar efficacy and safety to reference biologics, can alleviate the financial burden associated with current anti-VEGF therapies.

“The launch of Byooviz, the first ophthalmology biosimilar in the United States, marks a key step towards increasing options and reducing the financial burden associated with current anti-VEGF treatments,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.

Byooviz, the first biosimilar launch in the United States under the Biogen and Samsung Bioepis’ partnership, was approved as the first ophthalmology biosimilar in Europe (2021), the United Kingdom (2021) and Canada (2022).

The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, Byooviz and SB15, a biosimilar candidate referencing Eylea (aflibercept).

“The priority of Samsung Bioepis is ensuring patients’ access to the medicines they need, and we will continue to advance our pipeline to bring better access to biologic treatments by leveraging our decade of experience in developing, manufacturing and commercializing these important biologics,” Ko said. 

Samsung Bioepis is responsible for the development, regulatory registration and manufacture of the products while Biogen is responsible for commercialization. 


Babyganics expands mineral sunscreen range

babyganics mineral sunscreen line

Summer is just around the corner, and Babyganics is offering the proper sun protection for children and toddlers.

The San Francisco-based company is expanding its mineral sunscreen line with two new products that are designed for easy application:

  • B Kids SPF 50 Non-Aerosol Sunscreen Spray, featuring a continuous mist, is designed for application on such larger body parts as arms, backs and legs; and
  • Babyganics Kids Roll On 50 SPF, ideal for those itty-bitty-tricky-to-reach places, the rollerball is able to run in easily into such areas as ear lobes and the tops of feet to provide smooth coverage.

Made with an all mineral active ingredient formula that is free of parabens, phthalates, PABA, fragrances and nanoparticles, each product offers broad-spectrum SPF 50 UVA/UVB protection. They are also sweat- and water-resistant up to 80 minutes, dermatologist tested, pediatrician tested, non-allergenic, tear-free and not tested on animals, the company said.

Babyganics’ new mineral sunscreen spray and roll-on are available online, as well as at retailers nationwide.


Hyland’s Naturals caters to specific health goals with gummy line

Hyland’s Naturals gummies

Hyland’s Naturals is unveiling a new line of gummies that fall into the vitamins, minerals and supplements category.

Featuring four new preventive health supplements for adults and children, the organic and vegan gummies are formulated to target specific health goals that range from immune support and stress relief to digestive health, the company said.

“Hyland’s Naturals has been a trusted wellness brand with families for more than a century, and we’re thrilled to now offer customers our high-quality gummy supplements for preventative health,” said Will Righeimer, CEO of Hyland’s Naturals. “Not only do our gummy supplements taste delicious, but they are also manufactured in the USA to ensure the highest level of safety and quality for our consumers.”

The new gummies include:

  • Organic Elderberry Plus, a daily immune support product that contains black elderberry, vitamin C and zinc;
  • Kids Organic Elderberry Plus, a daily immune support supplement with organic black elderberry, vitamin C and zinc;
  • Organic Apple Cider Vinegar Blast, a supplement formulated to support digestive health with such antioxidants as apple cider vinegar; and
  • Stress Busters, made with L-theanine, lemon balm and chamomile. It provides a nondrowsy solution to quiet the mind for relaxation or focus.

Consumers can find Hyland’s Naturals’ new supplements at more than 15,000 retail locations, six countries and all major e-commerce sites this quarter, the brand said.


FDA approves Roche’s Evrysdi for use in babies under 2 months old with SMA

The words approved in red capitalized letters

The Food and Drug Administration has granted Roche a label extension for Evrysdi (risdiplam) to include babies under two months old with spinal muscular atrophy.

SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

“The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, Rainbowfish principal investigator and director of the Experimental Neuroscience Program at St. Jude Children’s Research Hospital. “With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed.”

“The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults. We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers.”

Evrysdi is a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.


Accord launches generic Alimta

vial generic injectable teaser

Accord is offering pemetrexed lyo. injection, a new product in its line of chemotherapy drugs.

The drug is formulated as a sterile lyophilized (freeze-dried) powder to be reconstituted for intravenous infusion. Pemetrexelyo. injection is the generic of Eli Lilly’s Alimta.

It is used to treat non-squamous non-small cell lung cancer and malignant pleural mesothelioma, a cancer of the inside lining of the chest cavity.

Accord's generic product is offered in vials of 100-mg, 500-mg and 1,000-mg strengths, and is currently available to ship.

Pemetrexed lyo. injection is FDA approved for use as a first-line treatment for locally advanced or metastatic NSCLC with non-squamous tissue type, a maintenance drug for metastatic NSCLC, a treatment for NSCLC that recurs after prior chemotherapy and a treatment for MPM in patients whose cancer can't be removed surgically.

"Accord Healthcare US has distinguished itself in oncology injectables, and the introduction of pemetrexed lyo. injection to our portfolio strengthens our offering of oncology medications," said Accord CEO Jeff Hampton. "We are committed to making more generics available to patients. Our technical capabilities and manufacturing infrastructure have defined our company's history and the patients shape our future."


Dr. Reddy's intros generic Alimta

generic vial teaser

Dr. Reddy’s is offering pemetrexed for injection.

Alimta is approved in combination with Keytruda (pembrolizumab) immunotherapy and platinum chemotherapy (carboplatin or cisplatin, two other chemotherapy drugs) as the first treatment for nonsquamous non-small cell lung cancer that has spread with no abnormal EGFR or ALK genes.

The medication is the generic of Eli Lilly’s Alimta (pemetrexed for injection).

The Alimta brand and generic had a market value of approximately $1.2 billion for the most recent 12 months ending in March 2022, according to IQVIA.

Dr. Reddy’s pemetrexed for injection is supplied in 100 mg and 500 mg single-dose vials.