Significant biosimilar activities this week include:
08 Oct 22 | US | Samsung to pursue adalimumab interchangeability in the US
In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will pursue interchangeability for Hadlima® (biosimilar adalimumab) in 2024. Hadlima was approved in the US in July 2019 and is expected to launch in the US from July 2023 pursuant to an agreement with AbbVie.
05 Oct 22 | EU | Celltrion to commence interchangeability trials of Yuflyma® (biosimilar adalimumab)
Celltrion announced the commencement of Ph III clinical trials regarding Yuflyma® (biosimilar adalimumab) in Estonia. This trial will run for 13 months and will be used to support Celltrion’s application for interchangeability in the US. Yuflyma was approved in the EU in February 2021, and in Canada in December 2021.
03 Oct 22 | US | FDA to pilot new biosimilar program under BsUFA III
The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable products and improve the efficiency of biosimilar product development. The program, set out briefly in the FDA’s Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), will comprise two demonstration projects. The first will evaluate the data required to meet safety standards for interchangeability, and may include researching approaches other than switching studies to meet the interchangeability standard. The second, evaluating opportunities to streamline biosimilar product development, will take into account scientific advancements in analytical and pharmacological assessments, as well as experience with prior product development and marketed biosimilar products. Both will investigate methodologies, such as in vitro and in silico methods, to predict immunogenicity.
The BsUFA provides a framework for the FDA to collect user fees from companies developing biosimilar and interchangeable biological products in return for committing to certain performance goals, which are periodically refreshed and reauthorised. BsUFA III comprises the second reauthorisation under this framework, and commences in October 2022, running until September 2027. As well as the science program, BsUFA III sets out a number of performance goals for the FDA, including review response times; procedures relating to clinical protocol evaluation, facilities inspection, FDA-sponsor meetings and human factors validation studies for biosimilar-device combination products; and timeframes for the publication of a range of new or revised draft guidance documents.
03 Oct 22 | US | Amneal launches Alymsys® (biosimilar bevacizumab) in the US
03 Oct 22 | US | Medicare Part B biosimilar payment commences
A temporary increase in medicare payments for qualifying biosimilars commenced under section 11403 of the Inflation Reduction Act. This temporary increase applies to biosimilars whose average sales price is not more than the price of the reference product. This provision is intended to increase competition in the marketplace and to improve access to medicines.
Pearce IP offers Australian based, life sciences focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance. Call us today on 02 9023 9988 or email info@pearceIP.law.Print Page Mail Article