Biosimilars | Wikipedia audio article
Channel: wikipedia tts
Date: 2019-03-27

This is an audio version of the Wikipedia Article:
https://en.wikipedia.org/wiki/Biosimilar


00:03:50 1 Approval processes
00:06:45 2 Background
00:13:45 3 European approvals of biosimilars
00:14:05 4 United States of America
00:14:15 4.1 BPCI Act
00:16:18 4.2 Data exclusivity
00:18:01 4.3 US approved biosimilars
00:18:12 4.4 Nomenclature
00:18:54 5 Market implications



Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago.

Learning by listening is a great way to:
- increases imagination and understanding
- improves your listening skills
- improves your own spoken accent
- learn while on the move
- reduce eye strain

Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone.

Listen on Google Assistant through Extra Audio:
https://assistant.google.com/services/invoke/uid/0000001a130b3f91
Other Wikipedia audio articles at:
https://www.youtube.com/results?search_query=wikipedia+tts
Upload your own Wikipedia articles through:
https://github.com/nodef/wikipedia-tts
Speaking Rate: 0.8660017311557185
Voice name: en-GB-Wavenet-C


"I cannot teach anybody anything, I can only make them think."
- Socrates


SUMMARY
=======
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, to the exact fermentation and purification process, or to the active drug substance, but they have access to the commercialized innovator product. Overall, it is harder to ascertain fungibility between generics and innovators among biologics than it is among totally synthesized and semisynthesized drugs. That is why the name "biosimilar" was coined to differentiate them from small-molecule generics. A simple analogy, often used to explain the difference, is to compare wine with soda pop. It is harder to say objectively that two bottles of wine from two wineries are "sufficiently interchangeable," because of differences in yeast strain, weather, and year of grape harvest, than it is to say that two bottles of soda pop of the same flavor coming from two bottling plants are "sufficiently interchangeable" because they contain the same flavoring powder.
Drug-related authorities such as the EU's European Medicines Agency (EMA), the US's Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics). They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product.
In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted to demonstrate their highly-similar properties. Therefore, EMA has granted a marketing authorisation for only a few biosimilars since 2006, including a monoclonal antibody, that was recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz.