What are follow-on biologics?
A follow-on biologic, or biosimilar, is similar to the brand-name (innovator) product made by the pharmaceutical or biotechnology industry. In contrast to a biologic, most commonly used drugs are synthesized via a chemical process.
What are follow-on drugs?
The term “me-too drug” or “follow-on drug” refers to a medication that is similar to a pre-existing drug, usually by making minor modifications to the prototype, reflected in slight changes in the profiles of side effects or activity, and used to treat conditions for which drugs already exist.
What is difference between NDA and BLA?
An NDA is an application to permit the sale and marketing of a new drug in the United States. Drugs that are approved via an NDA pathway are regulated under Section 505 of the Food, Drug, & Cosmetics (FD&C) Act. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.
When did biosimilars start?
The FDA approved the first biosimilar product for marketing in the United States in March 2015.
What is a follow-on generic?
A generic drug is a product that is shown to be the same as an innovative drug, and is generally designated as therapeutically interchangeable with the innovator drug. Unlike generic drugs, a follow-on biologic (or “biosimilar”) is a product that is similar to, but not the same as, the innovator drug.
What is the difference between follow-on biologic and biosimilar?
Follow-on biologics are copies of the original innovator biologics. It is not possible to copy their structure exactly, leading to possible differences in efficacy and safety. Thus, regulations involving biologics are complex. Biosimilars are follow-on biologics which have been approved via the PHS Act.
Which of the following is a prodrug?
Examples of prodrugs that exist naturally or were produced unintentionally during drug development include aspirin, psilocybin, parathion, irinotecan, codeine, heroin, L-dopa, and various antiviral nucleosides.
What is IND in pharma?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Is insulin a biologic?
Biologic medication: Biologic medications are large, complex molecules, often made from living cells or tissue. Insulin, Victoza® and Trulicity® are examples of biologic medications that help manage diabetes. Drugs: Drugs are smaller molecules that are made through a chemical process.
What is the difference between a drug and a biologics?
In the United States, biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA’s Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research.
What are biologics and why are they important?
Important biologics include: Whole blood and other blood components Organs and tissue transplants Stem cell therapy Antibodies for passive immunization (e.g., to treat a virus infection) Human breast milk Fecal microbiota Human reproductive cells
What are the who guidelines for the evaluation of biosimilars?
The World Health Organization (WHO) published its “Guidelines for the evaluation of similar biotherapeutic products (SBPs)” in 2009. The purpose of this guideline is to provide an international norm for evaluating biosimilars.
When was the pathway for Biosimilars Act introduced?
On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House. See the Library of Congress website and search H.R. 1548 in 111th Congress Session. Since 2004 the FDA has held a series of public meetings on biosimilars.