What is Biologx?

BiologX is an early stage company focused on reducing the cost of life-saving drugs.  The Company has developed unique and proprietary methods to produce these drugs at markedly lower costs. BiologX’s initial focus and Proof of Concept will be on insulin, then insulin analogues, due to a large and increasing need, and lack of innovation. Initial work shows biosimilarity with two branded varieties of insulin currently available.
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Who makes up the BiologX Executive Management team and Board of Advisors?

You can learn more about the Executive Management team and Board of Directors in the Leadership section of this site. 
 
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Whom should I contact regarding investor inquiries?

Please feel free to contact us at your convenience.
 
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When was BiologX founded?

Biologx, Inc., was founded in November, 2020.
 
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Where is BiologX's corporate headquarters?

Our corporate headquarters are located at:
BiologX, Inc.
2802 Flintrock Trace
Suite 303
Austin, TX 78738
 
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Where is the company incorporated?

Wyoming
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Where can I find out more about BIologX?

Feel free to explore other parts of our site to find out more about BiologX, or contact us with inquiries.
 
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How can I view Biologx's Reg A+ Offering Circular?

BiologX, Inc.’s Offering circular can be found here, and all documents filed with the SEC on www.sec.gov
 
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What is a Biologic?

A biologic is a type of drug that is made from sugars, proteins, nucleic acids, or combinations of these. Biologics, like other drugs, are used for the treatment, prevention or cure of diseases such as diabetes and cancer. They include vaccines, gene therapy, and therapeutic proteins like monoclonal antibodies. Some immunotherapies are actually proteins that are given to patients to help turn on their immune systems. Biologic agents are made from natural and living sources and have a large, complex structure. In other words, “biologic” refers to genetically engineered proteins produced by living cells. 
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What is a Biosimilar?

A biosimilar is a biologic product that is developed to be highly similar to (work like) a biologic drug (reference product) that is currently on the market. These biosimilar drugs work in the body like the reference biologic, and must be proven to show no clinically meaningful differences in purity, safety, and effectiveness from the reference product. Like biologics, they are carefully monitored to ensure consistent quality.
 
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What does "clinically meaningful differences" mean to me?

This means that the biosimilar drug and the reference biologic drug have the same effect in terms of safety, efficacy and side effects when used to treat a patient. 
 
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Is a biosimilar a generic drug?

While it  is easy to make an analogy between these two types of drugs, the term biosimilar is used when talking about biologic drugs. Biologic drugs tend to be complex agents created from living cells, and biosimilar drugs are made to be “highly similar.” Generic drug is a term used for drugs that are not biologic agents but are chemically synthesized products that can be copied. 
 
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Why are Biosimilars being developed?

Biosimilars are being developed worldwide to help decrease the overall cost of drug therapy in healthcare. Biologics tend to be expensive. The hope is that the introduction of competition into the healthcare marketplace, without decreasing efficacy, will help reduce costs. The intended result is that more patients will have access to important biologic therapies by using biosimilars. It also allows for greater development of other drugs. 
The benefit for a specific individual may be based on a lower cost to them and/or their insurer. The efficacy and the biologic effect should be the same. 
 
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How are Biosimilars approved by the FDA?

Biosimilars use an abbreviated FDA process known as the 351(k) pathway. Biosimilar manufacturers must prove that the biologic product is highly similar to the originator or reference biologic. It must be demonstrated that there are no clinically meaningful differences in purity, safety, and potency when compared to the reference product. The comparability exercise used to demonstrate that a biosimilar is “highly similar” to a reference biologic is scientific, robust, and regulated. 
 
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What are the FDA's goals for Biosimilars?

The FDA created four goals to accelerate biosimilar competition: 
·   Improve efficiency of the biosimilar and interchangeable product development and approval process 

·   Maximize scientific and regulatory clarity for the biosimilar product development community 

·   Develop effective communications to improve understanding of biosimilars among patients, providers, and payers 

·   Support market competition by reducing attempts to unfairly delay market competition of follow-on products 

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