Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.
Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.
Mylan said that the FDA’s feedback leads it to believe that the biosimilar approval pathway is viable for this product, and that Mylan could be the first developer to commercialize a biosimilar onabotulinumtoxinA.
The originator onabotulinumtoxinA, a neuromuscular blocking agent, is approved to treat conditions including incontinence due to neurological conditions, prophylaxis of headache in patients with migraine, upper limb spasticity, cervical dystonia, and strabismus, among other indications, such as its cosmetic uses.
Mylan’s development partner for the candidate, Revance, said that successful completion of a biosimilar program could result in FDA approval for all 11 FDA-approved indications for the reference product, and Revance’s president and chief executive officer said in a recent earnings call that “we know what needs to be done, and the FDA has set the right level of expectations” for biosimilar approval.
Allergan and Medytox, makers of the brand-name Botox, face a recent competitor, the recently FDA-approved prabotulinumtoxinA-xvfs, marketed as Jeuveau. Despite being a purified botulinum toxin type A, like the innovator Botox, the newly authorized product was submitted to the FDA under a new Biologics License Application, and was not treated as a biosimilar of the innovator Botox. Its developer, Evolus, in partnership with drug maker Daewoong, sought only indications for the product’s aesthetic use, and the product is not approved for medical indications.
Allergan and Medytox are hoping to block Jeuveau’s sales in the United States; the companies filed a complaint with the US International Trade Commission in which they asked for an investigation into Evolus’ manufacturing of botulinum toxin products. While details of the complaint are confidential, Bloomberg reported that Allergan and Medytox have alleged that the rival product was developed using manufacturing secrets stolen by an Evolus employee.
Allergan and Medytox seek an immediate investigation into whether the product was developed, made, or imported using stolen secrets, and ask for Evolus to be prohibited from selling the drug in the United States.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Long-Term Data Support Use of Eculizumab Biosimilar as Soliris Alternative in PNH
January 28th 2025Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.