Report documents opportunities, challenges for biosimilars
NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.
The report, by auditing and finance firm Grant Thornton, argues that regulatory challenges, clinical trials and efficacy tests continue to present a “huge investment outlay.” Over the next four years, the report found, branded biologics representing $40 billion in sales will come off patent, not to mention the $20 billion worth of products already off patent.
The Generic Pharmaceutical Association, a trade group representing generic drug makers, said the report “underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments.”
“Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually,” GPhA president and CEO Ralph Neas said, calling for state legislatures to defeat what he called efforts by biotech drug makers Amgen and Genentech to limit future access to biosimilars.
A regulatory approval pathway for biosimilars was mandated in the Patient Protection and Affordable Care Act, and the Food and Drug Administration is currently in the process of developing regulations governing them.
FDA approves Perrigo testosterone gel
ALLEGAN, Mich. — The Food and Drug Administration has approved a testosterone gel product made by Perrigo, the drug maker said Tuesday.
Perrigo announced the approval of the testosterone gel in the 1% strength for the treatment of men with low or no testosterone.
The drug is bioequivalent to AbbVie’s AndroGel, which has annual sales of about $705 million, according to Symphony Health.
Rx Timer Cap introduces easy-to-remove version
LOS ANGELES — Rx Timer Cap has introduced a new version of the cap designed for ease of use among elderly patients.
The company announced Tuesday the introduction of the new EZ-Twist removal system for making the cap easy to open and close for people who don’t require childproof caps.
Like the original Rx Timer Cap, the EZ-Twist cap includes a built-in LCD timer that automatically counts the minutes and hours since the patient last took his or her medication. The cap’s bold red color differentiates it from the original, child-resistant cap, and the cap fits the Rexam Screw-Loc and Berry Friendly & Safe vials.