Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

How much the upcoming season will tax a health care system that has been stretched is unknown. However, a new report in JAMA Network Open offers a look at the similarities and differences between COVID-19 and seasonal influenza.1 >>>>>>>>>>>>>>>>>>>>>>>>>>>>>
The investigators ran a retrospective cohort study of children at the Children’s National Hospital in the District of Columbia. The children with influenza were diagnosed between October 1, 2019, and June 6, 2020. Children with laboratory-diagnosed COVID-19 were diagnosed between March 25, 2020, and May 15, 2020. The researchers looked at the rates of hospitalization, mechanical ventilator use, association between underlying medical conditions, and admission to the intensive care unit.

https://www.drugtopics.com/view/study-compares-clinical-features-of-covid-19-and-seasonal-influenza

estimated that the annual burden of influenza included 31.4 million outpatient visits, 334,185 hospitalizations, and direct medical costs of $10.4 billion.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5612050/

Can a biosimilar be approved for an indication that is approved for the reference product even if the biosimilar is not directly studied in that indication? >>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Yes, a biosimilar product may be approved for an indication without direct studies of the biosimilar in that indication. If the total evidence in the biosimilar application supports a demonstration of biosimilarity for at least one of the reference product’s indications, then it is possible for the biosimilar manufacturer to use data and information to scientifically justify approval for other indications that were not directly studied by the biosimilar manufacturer. This concept is called “extrapolation” and is critical to the goals of an abbreviated pathway—improving access and options at a potentially lower cost.

https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval

Biosimilars raise complex questions for patients, doctors and regulators. Unlike generics, which are exact copies of the chemical medicines they are modeled after, biosimilars retain slight differences from the original biologic medicines.1 These differences exist because biologics and biosimilars are made with distinct strains of living cells resulting in medicines that can’t be identically copied.1 >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
There are specific considerations involved in the approval process for biosimilars. The U.S. Food and Drug Administration (FDA) requires the maker of a biosimilar to show that its medicine, when compared to the original biologic, functions the same and is made up of similar components. More specifically, biosimilars must react the same way in the body — a concept known as pharmacokinetics and pharmacodynamics (PK/PD) — and have equivalent effectiveness and safety as the original biologic.2 >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
One specific consideration relevant to the FDA and important for doctors and patients to understand is extrapolation. This concept allows the maker of a biosimilar to perform clinical trials in one appropriate disease and then potentially use the data to support the approvals for all of the original medicine’s approved indications. For example, the immunosuppressant medicine infliximab has been studied in and received approval to treat six conditions, including rheumatoid arthritis, Crohn’s disease and plaque psoriasis. The FDA has approved two biosimilar versions of infliximab for all six, even though they only underwent testing for a few of those...

https://www.gene.com/stories/extrapolation-explained