Biosimilars
Amgen announces positive phase III results for ustekinumab biosimilar
Amgen has announced positive results from a phase III trial of its ustekinumab biosimilar, ABP 654. The trial met its primary endpoint, demonstrating no clinically meaningful differences with the originator product, Stelara.
HHS new study on biosimilar use and expanded trials will include older patients
In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.
Regulating drug prices in Medicare unlikely to lead to ‘revenue targeting’
A report from the American Enterprise Institute (AEI) suggests that regulating drug prices in Medicare is unlikely to lead manufacturers to compensate by increasing revenues from the commercial market, based on analysis of similar events in the European Union (EU).
Needle-free delivery of biological drugs from Rani and Progenity
Rani Therapeutics and Progenity have announced the respective launch and development of new oral, needle-free methods to deliver large biological drug molecules.
Secondary patents delay access to biosimilars in the US
Biological drug patents covering new methods of manufacturing and formulation are major contributors to delays in biosimilar market entry in the US, finds a new study published in Nature Biotechnology [1].
FDA approves Kashiv Biosciences’ filgrastim biosimilar
The US Food and Drug Administration (FDA) has approved a filgrastim biosimilar produced by India-based Kashiv Biosciences. The biosimilar will be marketed under the trade name Releuko (filgrastim-ayow).
British Columbia adds coverage for three new enoxaparin biosimilars
British Columbia, Canada has added PharmaCare coverage for three new enoxaparin biosimilars, a blood thinner used to prevent and treat blood clots.
Celltrion updates on Remsima and Yuflyma
South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.
Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz
Byooviz (SB11) is the first ranibizumab biosimilar approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) [1, 2].
Biocomparables approved in Mexico
In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).
