Nation's largest Albuterol Sulfate manufacturer Implements Albuterol Sulfate Emergency Strategy for the U.S.
COLUMBIA, S.C., April 25, 2023 /PRNewswire/ -- The Ritedose Corporation (Ritedose), an industry leader in pharmaceutical development, aseptic cGMP manufacturing and 503B outsourcing solutions, has begun production of a particular form of Albuterol Sulfate that the FDA has listed in short supply in the United States. It will be available in May.
Ritedose is the nation's largest Albuterol Sulfate inhalation solution manufacturer.
In March, the U.S. Food and Drug Administration (FDA) announced a drastic downturn in the nation's supply of Albuterol Sulfate (0.5% Inhalation Solution). The medication, a breathing treatment for asthma and certain types of chronic obstructive pulmonary disease (COPD), is considered an "essential medication" by the FDA, with the 0.5% Inhalation Solution having an annual demand of nearly 20 million doses per year. Until recently, the 5mg/ml concentration was supplied to the market by Akorn, Inc and Nephron Pharmaceuticals.
"Major shifts in the market's ability to meet demand has driven our rapid response," said Jody Chastain, CEO of The Ritedose Corporation. "Our manufacturing flexibility is ideally suited to step into this role. The Ritedose Corporation's 503B Outsourcing Facility will be distributing Albuterol 0.5% [5 mg/mL] 75 mg/15 mL in Blow Fill Seal (BFS) ampoules that will return stability to the market and ease concerns for healthcare providers and Albuterol patients across the country."
While products produced through the 503B manufacturing process are prohibited from being sold and distributed via wholesalers, Ritedose will compound the 5mg/ml concentration of Albuterol Sulfate with distribution directly to hospitals and clinicians under the current drug shortage. Working with several of the large hospital systems in the nation allowed Ritedose to accelerate development from a typical six-month timeframe down to a record timeline of only four months, as the need for quality supply outpaced the desire for a longer shelf life.
"Our team at Ritedose knows what 'rolling up our sleeves' looks like, as we were in the trenches helping with the Covid crisis and will do the same with this shortage," continued Chastain. "We are all about patient safety and reliability—the U.S. can count on us to step-up and solve the drug shortage gap of Albuterol Sulfate."
For long-term supply chain continuity, Ritedose will be submitting an additional Abbreviated New Drug Application (ANDA) in other container sizes to meet supply demands.
Founded in 1995 in Columbia, South Carolina, The Ritedose Corporation is an industry leader in the aseptic manufacturing and liquid packaging of drug products and utilizes proven Blow-Fill-Seal (BFS) equipment and processes to ensure efficient, consistent and safe dosage delivery. The company's 27-year track record includes delivery of more than 8 billion doses since 2012 without interruption, and its current capacity is 2 billion units annually. To learn more about all Ritedose products, view the product catalog or email us at [email protected] with order information.
Amgen estimates that biosimilars resulted in $3.2 billion in savings last quarter alone, according to its latest trend report. And though the last two years saw a decline in overall approvals, the number of programs in development — and the uptake of available biosimilars — is on the rise.
The team at Amgen took a deeper look at the US FDA’s 39 approved biosimilars — cheaper treatments that are just as safe and effective as their costly original biologics — and those still in development in its ninth annual
Although only 22 of those products have launched on the market, Amgen approximates that they’ve created around $21 billion in savings over the last six years.
“These new biosimilars have the potential to generate even more savings for the healthcare industry, which can then be deployed to newer, innovative treatments,” said Amgen, which has five biosimilars on the market.
Despite just four biosimilars winning approval last year, Cardinal Health called it one of the “most eventful” in US history, adding in a recent report that momentum in the space is “stronger than ever.”
Last year’s milestones included Viatris’ Semglee approval as the first interchangeable biosimilar, the first interchangeability designation for AbbVie’s blockbuster Humira, and Biogen’s OK for Byooviz, the first approved biosimilar in ophthalmology.
“Prior to this year, it was predominantly oncology-focused medications, a little bit of rheumatology and then for only two months of 2021 was the insulin launch. Now we have two launches of biosimilars in the retina space, more products in oncology and then we have the first full year of the insulin,” Cardinal’s director of biosimilars, Jeff Baldetti, told
Six biosimilars have won approval so far this year, surpassing the four and three products approved in 2021 and 2020, respectively. That dip came after a record 2019, which brought 10 new approvals and 7 launches.
Mizuho analyst Salim Syed noted in an email to investors on Thursday that the 2020-2021 decline was “possibly pandemic-related in part.”
“Although there was an overall decline in the number of approvals during the 2020 to 2021 timeframe, the number of development programs that are participating in the FDA’s Biosimilar Development Program has continued to rise,” Amgen noted in its report.
The biosimilars field has taken off since the first approval came through in 2015 for Zarxio, a version of Amgen’s white blood cell booster Neupogen. While the EU beat the US to its first biosimilar by several years, the bloc saw just 15 biosimilar approvals in the eight years after its first OK from 2006 to 2013, and the US has seen 39 approvals from 2015 to 2022. Progress in the US has picked up, experts say, despite pushback and patent litigation from pharma companies making top-dollar on their original biologics.
Plus, uptake continues to climb, Amgen noted. Biosimilars launched in the last three years hold 75% of the market on average, according to the report. And the Inflation Reduction Act, signed into law back in August, will temporarily raise Medicare’s reimbursement for qualifying biosimilars, potentially making them more attractive to prescribe.
“The temporary Medicare Part B payment increase for qualifying biosimilars that is now in effect will foster competition in the drug marketplace for conditions such as diabetes, cancer, and immune disorders, and will improve access to these life-saving medicines that help keep people with Medicare healthy,” CMS administrator Chiquita Brooks-LaSure said in a statement earlier this month.
“I think that, in general, it’s going to be the beginning of an exciting year for biosimilars,” Baldetti said. “Probably the beginning of probably two years that [are] going to be quite a remarkable change as we see the evolution of a much more robust biosimilar market in the retail space.”
Despite satisfaction among gastroenterologists and allergists who have trialed the drug, high patient out-of-pocket costs and reimbursement hassles could hamper future prescribing
EXTON, Pa., Oct. 14, 2022 /PRNewswire/ -- In May of 2022, Sanofi/Regeneron's Dupixent (dupilumab) was granted approval by the U.S. FDA to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older, making the IL-4/13 inhibitor the first approved treatment for this debilitating disease. Spherix Global Insights' recent research via their
Launch Dynamix™: Dupixent in EoE
(US) service reveals swift uptake and unprecedented projected use of the brand at just three months post-approval. Indeed, nearly half of physicians (n=64 gastroenterologists and 10 allergists), sampled in September, report that they have already initiated trial of the drug in at least one EoE patient.
The vast majority of those reporting early experience also state that they are overall very satisfied with Dupixent. Indeed, the drug is poised to surpass other EoE treatments, with user-base projections expected to exceed 80% over the next six months, and brand share also anticipated to make substantial gains during that timeframe.
Though most surveyed physicians see Dupixent as an advance over existing treatment options, more than half acknowledge that Dupixent will be reserved for more severe patients who have failed other options and will likely be used as a third- or later-line agent. Key barriers for further penetration include patient out-of-pocket costs and insurance/reimbursement hassles. Specifically, one respondent stated, "well, elimination diet doesn't cost anything. If anything, it saves money. Some [proton] pump inhibitors are relatively cheap now that they're mostly generic and the budesonide slurry that we commonly use is generic as well, and then suddenly you've got a drug that costs thousands of dollars." Additionally, while less prohibitive to overall uptake, several respondents also note the subcutaneous injection administration and weekly dosing schedule could at some point also limit use as the agent continues to penetrate the market.
While Dupixent is undoubtedly filling a large unmet need in prescribers' EoE armamentarium, nearly one-third of respondents report that they have yet to see a Sanofi/Regeneron sales representative for the brand, an aspect that could potentially delay further uptake. Respondents specifically want the manufacturers and sales representatives to provide additional support navigating reimbursement hassles. One gastroenterologist suggests, "stay in close contact with my biologic coordinator, try to get patients access to this. Help, in any way, get the patient on the medication, whether it's financial, whether it's benefits verification, whatever it is."
Regardless of current barriers, Dupixent's status as the first-to-market treatment, well perceived safety profile, and sizeable stated candidate pool has poised the brand to alter the treatment landscape once again for patients suffering with auto-immune disease. Spherix will continue to monitor the adoption of Dupixent in EoE over the first eighteen months on the market, highlighting the brand's launch strategies and adoption patterns that will be key learnings for anyone with assets looking to enter the space.
About Launch Dynamix™
Launch Dynamix™ is an independent service providing a monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into patient types initiated, brand perceptions, promotional activity, and drivers and barriers to uptake. Learn more about our services here.
About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.
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Paul Zimmerman, Vice President, Insights
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SOURCE Spherix Global Insights