Biosimilars/General
American Academy of Ophthalmology biosimilars position statement published
The American Academy of Ophthalmology issued a policy statement on the use of biosimilars in ophthalmic practice in January 2022 [1].
US prescription drug expenditure projection report
United States expenditure on pharmaceuticals was up in 2021, finds a report published in American Journal of Health-System Pharmacy [1]. It also highlights that increased uptake of biosimilars is allowing for healthcare savings yet overall spending on drugs in the US will increase by up to 6% in 2022.
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.
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.
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.
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).
Consortium of US hospitals to manufacture and sell biosimilar insulin
A consortium of large US hospitals, through the non-profit company Civica Rx, are to manufacture and sell biosimilar insulin capped at US$30 per vial.
Biosimilars approved in Argentina
In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).
Key considerations when switching to biosimilar insulin
Biosimilar insulins can offer a cheaper alternative to originator insulators and substantial savings for healthcare systems. A recent ‘Quick guide: Initiating or switching to a biosimilar insulin’, [1] published in the Journal of Diabetes Nursing, outlines key aspects to consider when switching.
Nova Scotia, Canada implements biosimilar switching policy
Nova Scotia becomes the fifth Canadian province to implement a biosimilar switching policy, meaning that half of Canada’s provinces have now implemented such policies.
