Definitions for biosimilar
biosim·i·lar

WiktionaryRate this definition:0.0 / 0 votes

1. biosimilarnoun

   A variant of a biopharmaceutical that is marketed following the expiry of the original patent

WikidataRate this definition:0.0 / 0 votes

1. Biosimilar

   Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Biosimilars or follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics in Canada. Reference to the innovator product is an integral component of the approval. Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products can have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. Consequently only a few subsequent versions of biologics have been authorized in the US through the simplified procedures allowed for small molecule generics, namely Menotropins and Enoxaparin, and a further eight biologics through the 505 pathway.

How to pronounce biosimilar?

1. Alex

   US English

   David

   US English

   Mark

   US English

   Daniel

   British

   Libby

   British

   Mia

   British

   Karen

   Australian

   Hayley

   Australian

   Natasha

   Australian

   Veena

   Indian

   Priya

   Indian

   Neerja

   Indian

   Zira

   US English

   Oliver

   British

   Wendy

   British

   Fred

   US English

   Tessa

   South African

How to say biosimilar in sign language?

Numerology

1. Chaldean Numerology

   The numerical value of biosimilar in Chaldean Numerology is: 7

2. Pythagorean Numerology

   The numerical value of biosimilar in Pythagorean Numerology is: 8

Examples of biosimilar in a Sentence

1. David Wang:

   Some companies from a U.S. perspective are not novel, but for China ... they are a very novel thing, if you're a biosimilar company in the U.S. people don't believe that's going to be a big deal. However, in China biosimilar is big stuff.

2. The FDA:

   Biosimilars will provide access to important therapies for patients who need them, patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards.

3. Novartis AG unit Sandoz:

   Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product.

4. Accessible Medicines:

   We take all instances of illegal behavior seriously. Anyone convicted of violating these laws should be punished appropriately, vigorous, ethical competition is the foundation of the generic drug and biosimilar industry. Competition allows our companies to drive enormous savings and pass them on to patients, taxpayers and health care payors.

5. The FDA:

   Biosimilars will provide access to important therapies for patients who need them, patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.

References

1. ^ Wiktionary
   https://en.wiktionary.org/wiki/Biosimilar
2. ^ Wikidata
   https://www.wikidata.org/w/index.php?search=biosimilar